Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HWQ — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
449 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970360 | MITEK SUTURE RETROGRADER | Mitek Products | 1997-03-10 | 38 | 0 |
| K923381 | SOFT TISSUE EXPANDER | Acufex Microsurgical, Inc. | 1993-05-05 | 300 | 0 |
| K920621 | ACUFEX PASSING PINS AND SURGICAL WIRE | Acufex Microsurgical, Inc. | 1993-05-05 | 449 | 0 |
| K885311 | MENISCUS MENDER II LOOP | Instrument Makar, Inc. | 1989-02-09 | 42 | 0 |
| K843592 | VICO MICRO SURGICAL INSTRUMENTS | Visitec Co. | 1984-10-05 | 23 | 0 |
| K841622 | SOFT-TISSUE INSTRUMENT | Plastafil, Inc. | 1984-07-11 | 83 | 0 |
| K841623 | SLOTTED SOFT-TISSUE INSTRUMENT | Plastafil, Inc. | 1984-07-11 | 83 | 0 |
| K811679 | SILASTIC TENDON PASSER H.P. | Dow Corning Corp. Healthcare Industries Materials | 1981-07-10 | 25 | 0 |
| K791960 | ROTH-KENNEDY PASSER | 3M Company | 1979-10-04 | 3 | 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