Hospitech Respiration , Ltd.: FDA clearances and approvals
Hospitech Respiration , Ltd. has 6 FDA 510(k) clearances (first 2010, latest 2022), across 3 product codes in 2 review panels. Median 510(k) review time: 200 days. It is the industry lead sponsor of 4 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 132 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 389 |
| 2017 | 0 | — |
| 2018 | 1 | 179 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 220 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Hospitech Respiration , Ltd.'s cleared 510(k)s took a median 200 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 166 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BSK | Cuff, Tracheal Tube, Inflatable | 4 | 4 |
| BTP | Dropper, Ether | 1 | 1 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 | 1 |
Review panels
Most recent Hospitech Respiration , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221477 | AG100s | BSK | 2022-12-29 | 220 |
| K180991 | AG 100s | BSK | 2018-10-12 | 179 |
| K150157 | AnapnoGuard 100 Respiratory Guard System | BSK | 2016-02-16 | 389 |
| K131099 | AG MASS | JCX | 2013-05-13 | 24 |
| K122721 | AG GUFFILL | BSK | 2013-05-03 | 240 |
| K093126 | ANAPNOGUARD ENDOTRACHEAL TUBE | BTP | 2010-03-02 | 151 |
Recalls
openFDA lists no recalls under a recalling firm named Hospitech Respiration , Ltd..
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.
Device clinical trials
Hospitech Respiration , Ltd. is the industry lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01857986: Evaluating Air Leak Detection in Intubated Patients (Completed, started 2013-09)
- NCT01550978: Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System (Completed, started 2012-02)
- NCT01126320: Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated Patients Using the AnapnoGuard System (Completed, started 2010-12)
- NCT01188122: Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System (Completed, started 2008-04)
Frequently asked questions
How many FDA 510(k) clearances does Hospitech Respiration , Ltd. have?
Hospitech Respiration , Ltd. has 6 FDA 510(k) clearances (first 2010, latest 2022), across 3 product codes in 2 review panels.
How long does FDA take to clear Hospitech Respiration , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Hospitech Respiration , Ltd.'s cleared 510(k)s is 200 days.
What devices does Hospitech Respiration , Ltd. make?
Its most frequent FDA product codes are BSK (Cuff, Tracheal Tube, Inflatable, 4); BTP (Dropper, Ether, 1); JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered, 1).
Has Hospitech Respiration , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hospitech Respiration , Ltd. Related entities may recall under other names.
Next steps
- See all 6 Hospitech Respiration , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BSK, Hospitech Respiration , Ltd.'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.