Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BTK — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
40 daysmedian FDA review time
188 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944949 | GENERAL ANESTHESIA SYSTEM | Vital Signs, Inc. | 1994-11-14 | 38 | 1 |
| K914335 | STRAP, HEAD, GAS MASK | Vital Signs, Inc. | 1992-04-02 | 188 | 0 |
| K854537 | HEADSTRAP | Life Design Systems, Inc. | 1985-12-03 | 20 | 0 |
| K853573 | MEDIPART FACE MASK HEADSTRAP MP-9100 | Medipart Jerry Alexander | 1985-10-29 | 64 | 0 |
| K831008 | HEAD STRAP | Medovations, Inc. | 1983-05-09 | 40 | 0 |
| K810991 | HEADSTRAP | Respironics, Inc. | 1981-04-29 | 16 | 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