Minrad, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Minrad, Inc.” (first 1997, latest 2007), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 63 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 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 |
|---|---|---|---|
| CCW | Laryngoscope, Rigid | 3 | 3 |
| FMF | Syringe, Piston | 3 | 3 |
| KNW | Instrument, Biopsy | 3 | 3 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | 2 |
| CBN | Apparatus, Gas-Scavenging | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| MDM | Instrument, Manual, Surgical, General Use | 1 | 1 |
Review panels
Most recent Minrad, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072255 | MINRAD INC. NASAL SCAVENGING CIRCUIT | CBN | 2007-10-18 | 66 |
| K071814 | LIGHT SABRE SPINAL ACCESS DEVICE | KNW | 2007-10-16 | 106 |
| K062231 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 | CCW | 2006-08-31 | 29 |
| K062230 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 | CCW | 2006-08-31 | 29 |
| K041852 | MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 | CCW | 2004-11-15 | 130 |
| K041846 | SABRESOURCE DRAPE | KKX | 2004-08-26 | 49 |
| K021084 | LIGHT SABER SPINAL NEEDLE | FMF | 2002-07-03 | 90 |
| K013040 | LIGHT SABER INTRODUCER NEEDLE | MDM | 2001-12-07 | 88 |
| K982735 | LIGHT SABER BONE BIOPSY NEEDLE | KNW | 1998-09-09 | 35 |
| K982018 | LIGHT SABER ASPIRATION NEEDLE | FMF | 1998-08-07 | 60 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Minrad, 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 Minrad, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Minrad, Inc.” (first 1997, latest 2007), across 7 product codes in 4 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 Minrad, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Minrad, Inc. is 63 days.
Which FDA product codes appear under Minrad, Inc.?
The most frequent FDA product codes under this applicant name are CCW (Laryngoscope, Rigid, 3); FMF (Syringe, Piston, 3); KNW (Instrument, Biopsy, 3).
Next steps
- See all 14 Minrad, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CCW, Minrad, 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.