Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Accutron, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
128 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052335 | ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA | Accutron, Inc. | 2005-11-23 | 89 | 4 |
| K033503 | RFS VACUUM GAUGE SCAVENGING CIRCUIT | Accutron, Inc. | 2004-03-12 | 128 | 0 |
| K992421 | GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 | Accutron, Inc. | 1999-10-27 | 98 | 0 |
| K965239 | PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW | Accutron, Inc. | 1997-03-28 | 87 | 0 |
| K970046 | UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1 | Accutron, Inc. | 1997-03-28 | 81 | 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