Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neometrics, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
165 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152560 | Bard Snare Retrieval Kit | Neometrics, Inc. | 2015-10-23 | 44 | 0 |
| K150225 | NovaGold High Performance Guidewire | Neometrics, Inc. | 2015-03-16 | 42 | 0 |
| K143135 | Spring Coil Guidewire | Neometrics, Inc. | 2015-02-20 | 112 | 0 |
| K133076 | NOVAGOLD HIGH PERFORMANCE GUIDEWIRE | Neometrics, Inc. | 2014-02-20 | 143 | 1 |
| K123439 | NEO ERCP GUIDEWIRE | Neometrics, Inc. | 2013-01-03 | 56 | 0 |
| K101729 | NEOWIRE PTA/PTCA GUIDEWIRE | Neometrics, Inc. | 2010-09-23 | 94 | 0 |
| K070150 | VASCUPUNCTURE PICC GUIDEWIRE | Neometrics, Inc. | 2007-02-15 | 30 | 0 |
| K043398 | MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE | Neometrics, Inc. | 2005-03-01 | 81 | 0 |
| K040786 | VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING | Neometrics, Inc. | 2004-04-19 | 21 | 0 |
| K033321 | SELECTIVA SB GUIDEWIRE | Neometrics, Inc. | 2003-11-05 | 21 | 0 |
| K031652 | VASCUPUNCTURE PICC GUIDEWIRE | Neometrics, Inc. | 2003-09-30 | 125 | 0 |
| K012861 | VASCUPUNCTURE ACCESS WIRE | Neometrics, Inc. | 2002-02-05 | 165 | 0 |
| K013024 | SELECTIVA GUIDEWIRE | Neometrics, Inc. | 2001-12-04 | 88 | 0 |
| K001455 | ACCUWELL TSH, MODEL KAW-TSH-960 | Neometrics, Inc. | 2000-11-02 | 177 | 0 |
| K991498 | ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL | Neometrics, Inc. | 1999-06-16 | 48 | 0 |
| K974047 | ACCUWELL PHENYLALANINE ASSAY | Neometrics, Inc. | 1997-12-05 | 42 | 0 |
| K972974 | ACCUWELL T4-EIA | Neometrics, Inc. | 1997-10-06 | 56 | 0 |
| K934178 | ACCUSCREEN 17-HYDROXYPROGESTERONE | Neometrics, Inc. | 1995-03-30 | 580 | 0 |
| K901939 | NEOCOAT T4 | Neometrics, Inc. | 1990-05-31 | 31 | 0 |
| K843281 | ACCUSCREEN TSH | Neometrics, Inc. | 1984-09-26 | 37 | 0 |
| K781222 | ACCUSCREEN T4 | Neometrics, Inc. | 1978-11-08 | 114 | 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