Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smith and Nephew Donjoy, Inc. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
272 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970051 | MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE | Smith and Nephew Donjoy, Inc. | 1997-07-10 | 184 | 0 |
| K963492 | PROTECTIVE RESTRAINT | Smith and Nephew Donjoy, Inc. | 1996-11-12 | 70 | 0 |
| K963490 | PROTECTIVE RESTRAINT - BELTS | Smith and Nephew Donjoy, Inc. | 1996-11-12 | 70 | 0 |
| K963489 | WHEEL CHAIR ACCESSORY | Smith and Nephew Donjoy, Inc. | 1996-11-12 | 70 | 0 |
| K962462 | MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR | Smith and Nephew Donjoy, Inc. | 1996-09-23 | 90 | 0 |
| K955057 | MODEL 1100 COLD THERAPY DEVICE | Smith and Nephew Donjoy, Inc. | 1996-03-08 | 123 | 0 |
| K951350 | MUSCLESENSE ELECTROMYOGRAPHY DEVICE | Smith and Nephew Donjoy, Inc. | 1995-06-23 | 91 | 0 |
| K945687 | ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW | Smith and Nephew Donjoy, Inc. | 1995-06-22 | 213 | 0 |
| K946313 | TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER | Smith and Nephew Donjoy, Inc. | 1995-03-17 | 79 | 0 |
| K945236 | AIMS CANNULATED ACL SCREW (7MM DIAMETER) | Smith and Nephew Donjoy, Inc. | 1995-02-03 | 99 | 0 |
| K932592 | BRACE NEUTRALIZER | Smith and Nephew Donjoy, Inc. | 1994-03-18 | 294 | 0 |
| K932862 | ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW | Smith and Nephew Donjoy, Inc. | 1994-03-10 | 272 | 0 |
| K934044 | ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SY | Smith and Nephew Donjoy, Inc. | 1994-03-10 | 203 | 0 |
| K932320 | NEUTRALIZER | Smith and Nephew Donjoy, Inc. | 1993-10-06 | 148 | 0 |
| K903823 | SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE | Smith and Nephew Donjoy, Inc. | 1991-01-16 | 149 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda