Hospitak, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Hospitak, Inc.” (first 1978, latest 1996), across 22 product codes in 4 review panels. Median 510(k) review time under this name: 28 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 2 | 2 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | 2 | 2 |
| BZA | Connector, Airway (Extension) | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| KPJ | Chamber, Oxygen, Topical, Extremity | 2 | 2 |
| BSJ | Mask, Gas, Anesthetic | 1 | 1 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
| BXH | Gauge, Gas Pressure, Cylinder/Pipeline | 1 | 1 |
| BYG | Mask, Oxygen | 1 | 1 |
Plus 12 more product codes.
Review panels
Most recent Hospitak, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955483 | TRACH MASK MODEL (245, 246) | BYF | 1996-02-28 | 89 |
| K954787 | ILLUMINATOR | CCW | 1996-01-31 | 105 |
| K953620 | WARM N WET HMEF W/LUER ADAPTER | BYD | 1995-08-25 | 22 |
| K953619 | WARM N WET HME W/LUER ADAPTER | BYD | 1995-08-25 | 22 |
| K915750 | DISPOSABLE BACTERIAL BREATHNG FILTER | CAH | 1994-11-30 | 1077 |
| K920842 | AEROSOL DELIVERY SYSTEMS | LRD | 1992-05-15 | 81 |
| K915228 | DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL | CCK | 1992-02-11 | 83 |
| K873286 | DISPOSABLE, MANUAL PULMONARY RESUSCITATOR | BTM | 1987-10-26 | 70 |
| K853600 | INFLATABLE AIR SPLINTS | FZF | 1985-09-19 | 23 |
| K844328 | OXYGEN CONCENTRATOR | CAW | 1984-12-04 | 27 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hospitak, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Hospitak, Inc. (a text match, not an official crosswalk):
- A4575 — Topical hyperbaric oxygen chamber, disposable (via KPJ)
- G0379 — Direct admission of patient for hospital observation care (via CAF)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hospitak, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Hospitak, Inc.” (first 1978, latest 1996), across 22 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hospitak, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hospitak, Inc. is 28 days.
Which FDA product codes appear under Hospitak, Inc.?
The most frequent FDA product codes under this applicant name are BYD (Condenser, Heat And Moisture (Artificial Nose), 2); BYF (Mask, Oxygen, Low Concentration, Venturi, 2); BZA (Connector, Airway (Extension), 2).
Next steps
- See all 27 Hospitak, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BYD, Hospitak, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.