Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Remington Medical, Inc. · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
272 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Pro | Remington Medical, Inc. | 2025-11-20 | 153 | 0 |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Pro | Remington Medical, Inc. | 2024-08-30 | 88 | 0 |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Pro | Remington Medical, Inc. | 2022-01-27 | 248 | 0 |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Pro | Remington Medical, Inc. | 2021-10-07 | 97 | 0 |
| K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC) | Remington Medical, Inc. | 2019-07-12 | 58 | 1 |
| K150266 | Remington Medical Inc. Tuohy Epidural Needles | Remington Medical, Inc. | 2015-06-04 | 120 | 0 |
| K130282 | REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT | Remington Medical, Inc. | 2013-05-13 | 97 | 0 |
| K050884 | ADAPTER CABLE | Remington Medical, Inc. | 2005-05-19 | 42 | 1 |
| K040266 | CORE NEEDLE BIOPSY | Remington Medical, Inc. | 2004-07-09 | 155 | 5 |
| K990428 | DRAINAGE BAG | Remington Medical, Inc. | 1999-08-12 | 182 | 2 |
| K983621 | NEEDLE GUIDE | Remington Medical, Inc. | 1998-11-03 | 19 | 0 |
| K982401 | PROSTATE BIOPSY NEEDLE | Remington Medical, Inc. | 1998-09-08 | 60 | 3 |
| K972134 | BAG DECANTER | Remington Medical, Inc. | 1997-08-26 | 81 | 0 |
| K971968 | SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) | Remington Medical, Inc. | 1997-07-23 | 56 | 2 |
| K953812 | GAUZE SPONGE | Remington Medical, Inc. | 1995-10-02 | 61 | 0 |
| K946060 | REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RM | Remington Medical, Inc. | 1995-04-27 | 146 | 0 |
| K940467 | REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601 | Remington Medical, Inc. | 1994-11-01 | 272 | 0 |
| K932370 | REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET | Remington Medical, Inc. | 1993-11-09 | 179 | 0 |
| K922009 | DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101 | Remington Medical, Inc. | 1993-02-25 | 302 | 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