Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dept. of the Army · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
298 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023969 | REACTIVE SKIN DECONTAMINATION LOTION | Dept. of the Army | 2003-03-25 | 116 | 1 |
| K934818 | HAND HELD DENTAL X-RAY DEVICE | Dept. of the Army | 1994-01-24 | 109 | 0 |
| K921613 | STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510 | Dept. of the Army | 1993-01-29 | 298 | 0 |
| K901760 | LITTER, FOLDING RIGID POLE, DECONTAMINABLE | Dept. of the Army | 1990-07-10 | 83 | 0 |
| K894455 | DECONTAMINATING KIT, SKIN: M291 | Dept. of the Army | 1989-08-15 | 21 | 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