Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GCB — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
231 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150800 | Valved Safety Centesis Catheter | B.Braun Medical, Inc. | 2015-11-12 | 231 | 0 |
| K974146 | PARACENTESIS CATHETER DEVICE | Allegiance Healthcare Corp. | 1998-01-28 | 86 | 0 |
| K930568 | ADAIR/VERESS NEEDLE INTRODUCER SET | Medical Dynamics, Inc. | 1993-07-22 | 177 | 0 |
| K923028 | TURKEL PNEUMOTHORAX KIT | Symbiosis Corp. | 1992-08-04 | 42 | 0 |
| K900374 | ADAIR/VERESS NEEDLE INTRODUCER SET | Medical Dynamics, Inc. | 1990-04-20 | 84 | 0 |
| K854327 | SUBCUTANEOUS TUNNELING NEEDLES & HANDLES | Concord Laboratories, Inc. | 1985-11-13 | 16 | 0 |
| K852428 | MANAN EPIDURAL NEEDLE | Manan Manufacturing Co., Inc. | 1985-06-27 | 20 | 0 |
| K780896 | NEEDLES, DESIGN CHANGE, IV CATHETERS | Jelco Laboratories | 1978-08-23 | 85 | 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