Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GDT · Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
234 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963234 | STAPLE REMOVAL KIT | Continental Medical Laboratories, Inc. | 1996-10-21 | 63 | 0 |
| K943719 | VISISTAT STAPLER | Pilling Weck, Inc. | 1994-08-24 | 23 | 0 |
| K925526 | MANIPLER DISPOSABLE SKIN STAPLER | Matsutani Seisakusho Co. , Ltd. | 1993-06-24 | 234 | 0 |
| K915430 | SKIN STAPLE REMOVER KIT | Cypress Medical Products, Ltd. | 1992-02-28 | 88 | 0 |
| K911204 | QUALTEX SKIN STAPLE EXTRACTOR | Deroyal Industries, Inc. | 1991-05-08 | 50 | 0 |
| K910586 | AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* | United States Surgical, A Division of Tyco Healthc | 1991-03-07 | 24 | 0 |
| K900486 | APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER | Davis & Geck, Inc. | 1990-04-20 | 78 | 0 |
| K861711 | SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE | Busse Hospital Disposables, Inc. | 1986-05-16 | 11 | 0 |
| K851974 | V. MUELLER VITAL SKIN STAPLER | American V. Mueller | 1985-06-11 | 35 | 0 |
| K844838 | SKIN STAT II SKIN STAPLING MEDICAL DEVICE | Edward Weck, Inc. | 1985-01-23 | 42 | 0 |
| K844837 | VISISTAT SKIN STAPLING DEVICE | Edward Weck, Inc. | 1985-01-23 | 42 | 0 |
| K833085 | STAPLE REMOVER SR300P | Prosper, Inc. | 1984-12-14 | 459 | 0 |
| K833357 | VYDAX 525-550 & 5100 FLUOROTELOMER | ETHICON, Inc. | 1983-12-12 | 75 | 0 |
| K832709 | SKIN STAPLING DEVICE SC2000 | Prosper, Inc. | 1983-09-26 | 45 | 0 |
| K822365 | CENTURION SKIN STAPLE REMOVER | Tri-State | 1982-08-27 | 21 | 0 |
| K821024 | DISP. SKIN STAPLER REMOVALBLE SKINSTAPLE | Howmedica Corp. | 1982-05-14 | 31 | 0 |
| K801444 | SKIN STAPLE REMOVER #523770 | Edward Weck, Inc. | 1980-07-14 | 24 | 0 |
| K800535 | 3M DISPOSABLE SKIN STAPLER | 3M Company | 1980-04-04 | 25 | 0 |
| K760734 | REGULAR AND WIDE SKIN STAPLES | ETHICON, Inc. | 1976-11-03 | 36 | 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