Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smith & Nephew Dyonics, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
220 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955914 | LIMITED REUSE ARTHROSCOPIC BLADES | Smith & Nephew Dyonics, Inc. | 1996-02-08 | 55 | 0 |
| K954627 | ECTRA II LIGAMENT RELEASE SYSTEM | Smith & Nephew Dyonics, Inc. | 1995-12-18 | 73 | 0 |
| K954989 | DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES | Smith & Nephew Dyonics, Inc. | 1995-11-27 | 27 | 0 |
| K953695 | DYONICS DISPOSABLE ARTHROSCOPIC BLADES | Smith & Nephew Dyonics, Inc. | 1995-09-15 | 38 | 0 |
| K953387 | ECTRA LIGAMENT RELEASE SYSTEM | Smith & Nephew Dyonics, Inc. | 1995-08-09 | 21 | 0 |
| K945182 | DYONICS FIXATION SCREWS | Smith & Nephew Dyonics, Inc. | 1995-01-24 | 92 | 0 |
| K936071 | SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE | Smith & Nephew Dyonics, Inc. | 1994-08-19 | 242 | 0 |
| K934299 | DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION | Smith & Nephew Dyonics, Inc. | 1994-02-14 | 165 | 0 |
| K920267 | DYONICS ARTHROSCOPIC KIT | Smith & Nephew Dyonics, Inc. | 1993-03-23 | 427 | 0 |
| K922176 | INTELIJET SUCTION SUPPLY | Smith & Nephew Dyonics, Inc. | 1992-11-18 | 194 | 0 |
| K914963 | SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET | Smith & Nephew Dyonics, Inc. | 1992-06-04 | 212 | 0 |
| K913401 | SUCTION CONTROL FOOTSWITCH WITH SPEED CONTROL | Smith & Nephew Dyonics, Inc. | 1992-03-06 | 220 | 0 |
| K914559 | SMALL JOINT SYSTEM | Smith & Nephew Dyonics, Inc. | 1992-02-18 | 126 | 0 |
| K914919 | SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM | Smith & Nephew Dyonics, Inc. | 1992-01-09 | 66 | 0 |
| K913347 | PALMER ARCH SUPPRESSOR | Smith & Nephew Dyonics, Inc. | 1991-09-18 | 54 | 0 |
| K912453 | INTELIJET TM FLUID MANAGEMENT SYSTEM | Smith & Nephew Dyonics, Inc. | 1991-08-26 | 84 | 0 |
| K904284 | ARTHROSCOPIC SURGICAL BLADE | Smith & Nephew Dyonics, Inc. | 1990-12-05 | 79 | 0 |
| K903620 | MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM | Smith & Nephew Dyonics, Inc. | 1990-10-12 | 66 | 0 |
| K903193 | SMITH & NEPHEW DYONICS LEVELERT SYSTEM | Smith & Nephew Dyonics, Inc. | 1990-08-30 | 42 | 0 |
| K901765 | POSTEROMEDIAL GUIDE | Smith & Nephew Dyonics, Inc. | 1990-06-25 | 68 | 0 |
| K901616 | CANNULATED INTERFERENCE SCREW SYSTEM | Smith & Nephew Dyonics, Inc. | 1990-06-20 | 75 | 0 |
| K901505 | ARTHROSCOPIC ELECTROSURGICAL PROBE | Smith & Nephew Dyonics, Inc. | 1990-04-18 | 19 | 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