Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hospitech Respiration , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
220 daysmedian FDA review time
389 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221477 | AG100s | Hospitech Respiration , Ltd. | 2022-12-29 | 220 | 0 |
| K180991 | AG 100s | Hospitech Respiration , Ltd. | 2018-10-12 | 179 | 0 |
| K150157 | AnapnoGuard 100 Respiratory Guard System | Hospitech Respiration , Ltd. | 2016-02-16 | 389 | 0 |
| K131099 | AG MASS | Hospitech Respiration , Ltd. | 2013-05-13 | 24 | 0 |
| K122721 | AG GUFFILL | Hospitech Respiration , Ltd. | 2013-05-03 | 240 | 0 |
| K093126 | ANAPNOGUARD ENDOTRACHEAL TUBE | Hospitech Respiration , Ltd. | 2010-03-02 | 151 | 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