Accutron, Inc.: FDA clearances and approvals
Accutron, Inc. has 5 FDA 510(k) clearances (first 1997, latest 2005), across 3 product codes in 1 review panel. Median 510(k) review time: 89 days. openFDA lists 4 product recalls by a recalling firm named Accutron, Inc.
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 |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 2 | 2 |
| CBN | Apparatus, Gas-Scavenging | 2 | 2 |
| KHA | Mask, Scavenging | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Accutron, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052335 | ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA | BSZ | 2005-11-23 | 89 |
| K033503 | RFS VACUUM GAUGE SCAVENGING CIRCUIT | CBN | 2004-03-12 | 128 |
| K992421 | GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 | BSZ | 1999-10-27 | 98 |
| K970046 | UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) | KHA | 1997-03-28 | 81 |
| K965239 | PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) | CBN | 1997-03-28 | 87 |
Recalls
4 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-04-29.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Accutron, Inc. have?
Accutron, Inc. has 5 FDA 510(k) clearances (first 1997, latest 2005), across 3 product codes in 1 review panel.
How long does FDA take to clear Accutron, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Accutron, Inc.'s cleared 510(k)s is 89 days.
What devices does Accutron, Inc. make?
Its most frequent FDA product codes are BSZ (Gas-Machine, Anesthesia, 2); CBN (Apparatus, Gas-Scavenging, 2); KHA (Mask, Scavenging, 1).
Has Accutron, Inc. had device recalls?
openFDA lists 4 product recalls in 1 recall event by a recalling firm whose name matches Accutron, Inc; the most recent began 2012-04-29. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Accutron, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BSZ, Accutron, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.