Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GBW — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
62 daysmedian FDA review time
318 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992904 | MINI-PORT | Taut, Inc. | 1999-10-05 | 36 | 0 |
| K992907 | INTRADUCER | Taut, Inc. | 1999-10-05 | 36 | 0 |
| K972112 | INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 | Taut, Inc. | 1997-12-01 | 179 | 0 |
| K961194 | ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN | Sil-Med Corp. | 1996-08-08 | 134 | 0 |
| K960426 | MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER | Medical Components, Inc. | 1996-03-21 | 52 | 0 |
| K942709 | MEDIASTINAL SILICONE DRAINS | Sil-Med Corp. | 1996-01-04 | 575 | 0 |
| K933510 | ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER | Sherwood Medical Co. | 1994-02-24 | 219 | 0 |
| K926477 | BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO | Core Dynamics, Inc. | 1993-11-12 | 318 | 0 |
| K913733 | STERILE CHEST TUBE | Vascular Products, Inc. | 1991-10-08 | 49 | 0 |
| K894220 | HOUTS HYSTERECTOMY DRAIN | Helix Medical, Inc. | 1989-08-24 | 66 | 0 |
| K894119 | MADEGOM LTDA. PENROSE DRAIN TUBING | Madegom | 1989-08-18 | 67 | 0 |
| K854812 | NELSON-JUNG PLEURAL CATH | Research Medical, Inc. | 1986-02-11 | 70 | 0 |
| K843575 | DERBYSHIRE DRAIN | Sil-Med Corp. | 1984-10-24 | 43 | 0 |
| K813063 | FLAT DRAIN | Sil-Med Corp. | 1981-12-18 | 49 | 0 |
| K811627 | ARROW PERITONEAL LAVAGE CATHERIZATION K | Arrow Intl., Inc. | 1981-08-10 | 62 | 2 |
| K811378 | PERCUTANEOUS DRAINING CATHETER | Medi-Tech, Inc. | 1981-06-02 | 18 | 5 |
| K800422 | ADT MINI PERITONEAL LAVAGE KIT | A.D.T. Lab Industries | 1980-03-12 | 15 | 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