Table 1. Characteristics of the Medical Devices That Received 510(k) Clearance From the US Food and Drug Administration (FDA) by Recall Status.
| Recall status of medical devices that received 510(k) clearance | ||
|---|---|---|
| Recalleda | Not recalled | |
| No. of devices | 4007 | 31 169 |
| No. of unique manufacturersb | 994 | 4120 |
| No. of unique product typesc | 676 | 1326 |
| No. of deaths in MAUDE database | 24 918 | 4923 |
| Age of predicate medical devices, yd | ||
| Mean (SD) | 5.1 (4.2) | 5.4 (4.7) |
| Median (IQR) | 4.0 (2.1-6.9) | 4.1 (2.1-7.3) |
| Age of newest predicate medical devices, y | ||
| Mean (SD) | 3.1 (3.7) | 3.7 (4.4) |
| Median (IQR) | 1.8 (0.9-3.8) | 2.1 (1.0-4.7) |
| Age of oldest predicate medical devices, y | ||
| Mean (SD) | 7.4 (6.3) | 7.4 (6.3) |
| Median (IQR) | 5.8 (2.6-10.6) | 5.7 (2.6-10.4) |
| No. of predicate medical devices | ||
| Mean (SD) | 2.9 (3.4) | 2.5 (2.4) |
| Median (IQR) | 2 (1-3) | 2 (1-3) |
| No. of unique nonmatching product typese | ||
| Mean (SD) | 0.8 (1.2) | 0.6 (1.0) |
| Median (IQR) | 0 (0-1) | 0 (0-1) |
| No. of unique nonmatching medical specialtiese,f | ||
| Mean (SD) | 0.2 (0.5) | 0.2 (0.5) |
| Median (IQR) | 0 (0-0) | 0 (0-0) |
| No. of prior 510(k) clearances from the manufacturers | ||
| Mean (SD) | 74.4 (118.4) | 47.8 (98.5) |
| Median (IQR) | 21 (4-85) | 8 (2-40) |
| No. of prior 510(k) clearances from the manufacturers for the same product types | ||
| Mean (SD) | 5.4 (9.9) | 4.5 (9.4) |
| Median (IQR) | 2 (0-6) | 1 (0-4) |
| ≥1 Predicate medical devices received FDA clearance ≥10 y prior to FDA decision for applicant device, No. (%) | 1117 (27.9) | 8375 (26.9) |
| No. of ongoing class I or class II recalls for predicate medical devices, No. (%)g | ||
| 0 | 3439 (85.8) | 29 589 (94.9) |
| 1 | 346 (8.6) | 1180 (3.8) |
| 2 | 109 (2.7) | 249 (0.8) |
| ≥3 | 113 (2.8) | 151 (0.5) |
| ≥1 Ongoing class I or class II recalls for predicate medical devices by reason, No. (%)h | ||
| Miscellaneous | 236 (5.9) | 533 (1.7) |
| Software | 179 (4.5) | 326 (1.0) |
| Device design or component | 144 (3.6) | 352 (1.1) |
| Materials or composition | 87 (2.2) | 213 (0.7) |
| Manufacturing environment | 66 (1.6) | 230 (0.7) |
| Labeling | 41 (1.0) | 149 (0.5) |
| Packaging | 20 (0.5) | 84 (0.3) |
| Application | 3 (0.1) | 9 (<0.1) |
| Medical specialty of FDA review panel for applicant device, No. (%)i | ||
| Radiology | 777 (19.4) | 3678 (11.8) |
| Orthopedic | 759 (18.9) | 5996 (19.2) |
| Cardiovascular | 605 (15.1) | 3952 (12.7) |
| General and plastic surgery | 338 (8.4) | 3475 (11.1) |
| General hospital | 285 (7.1) | 2238 (7.2) |
| Clinical chemistry | 237 (5.9) | 1500 (4.8) |
| Gastroenterology and urology | 212 (5.3) | 1533 (4.9) |
| Anesthesiology and respiratory therapy | 209 (5.2) | 1490 (4.8) |
| Neurology | 150 (3.7) | 1238 (4.0) |
| Dental | 83 (2.1) | 2281 (7.3) |
| Microbiology | 67 (1.7) | 660 (2.1) |
| Hematology | 64 (1.6) | 310 (1.0) |
| Ophthalmic | 66 (1.6) | 632 (2.0) |
| Immunology | 38 (0.9) | 282 (0.9) |
| Obstetrics and gynecology | 37 (0.9) | 654 (2.1) |
| Ear, nose, and throat | 24 (0.6) | 350 (1.1) |
| Toxicology | 25 (0.6) | 277 (0.9) |
| Physical medicine | 20 (0.5) | 572 (1.8) |
| Pathology | 11 (0.3) | 51 (0.2) |
Abbreviation: MAUDE, Manufacturer and User Facility Device Experience.
Indicates whether a device experienced 1 or more class I or class II recalls between its FDA regulatory clearance date and December 31, 2020. Recalls are classified as class I when there is potential for serious patient harm or death and class II when there is potential for temporary or reversible patient harm or a slight chance of serious patient harm or death.
The variations on similar manufacturer names present in the FDA databases were standardized into a single manufacturer name (additional information appears in eAppendix 1 in Supplement 1).
These are FDA-assigned identifiers describing the generic function of a medical device (additional information appears in the study sample subsection of the Methods section).
Defined as the number of years between FDA clearance of a predicate device and clearance of an applicant device.
The data in these rows reflect dissimilarity between the applicant device and the predicate device.
There are 19 FDA medical specialty review panels that are responsible for reviewing a medical device. The medical specialty review panels are assigned based on a medical device’s product type.
Investigation has not yet terminated (resolved) for the predicate device at the time of FDA clearance for the applicant device.
Recalls were manually assigned to these categories based on the reason for recall (additional information appears in eTable 3 in Supplement 1).
The categories in this section are the specialty descriptions used by the FDA review panels.