Neometrics, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Neometrics, Inc.” (first 1978, latest 2015), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 56 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 56 |
| 2014 | 1 | 143 |
| 2015 | 3 | 44 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 9 | 9 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 3 | 3 |
| CDX | Radioimmunoassay, Total Thyroxine | 2 | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 2 |
| JIA | Enzymatic Methods, Galactose | 1 | 1 |
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | 1 | 1 |
| JNB | Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | 1 | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 | 1 |
| MMX | Device, Percutaneous Retrieval | 1 | 1 |
Review panels
Most recent Neometrics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152560 | Bard Snare Retrieval Kit | MMX | 2015-10-23 | 44 |
| K150225 | NovaGold High Performance Guidewire | OCY | 2015-03-16 | 42 |
| K143135 | Spring Coil Guidewire | DQX | 2015-02-20 | 112 |
| K133076 | NOVAGOLD HIGH PERFORMANCE GUIDEWIRE | OCY | 2014-02-20 | 143 |
| K123439 | NEO ERCP GUIDEWIRE | OCY | 2013-01-03 | 56 |
| K101729 | NEOWIRE PTA/PTCA GUIDEWIRE | DQX | 2010-09-23 | 94 |
| K070150 | VASCUPUNCTURE PICC GUIDEWIRE | DQX | 2007-02-15 | 30 |
| K043398 | MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE | DQX | 2005-03-01 | 81 |
| K040786 | VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING | DQX | 2004-04-19 | 21 |
| K033321 | SELECTIVA SB GUIDEWIRE | DQX | 2003-11-05 | 21 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Neometrics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Neometrics, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Neometrics, Inc.” (first 1978, latest 2015), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neometrics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neometrics, Inc. is 56 days.
Which FDA product codes appear under Neometrics, Inc.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 9); OCY (Endoscopic Guidewire, Gastroenterology-Urology, 3); CDX (Radioimmunoassay, Total Thyroxine, 2).
Next steps
- See all 21 Neometrics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Neometrics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.