Ventlab Corp.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Ventlab Corp.” (first 1989, latest 2018), across 18 product codes in 3 review panels. Median 510(k) review time under this name: 73 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 | 1 | 128 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 385 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ventlab Corp. took a median 385 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 238 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 | 2 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 2 |
| NHK | Resuscitator, Manual, Non Self-Inflating | 2 | 2 |
| BSJ | Mask, Gas, Anesthetic | 1 | 1 |
| BSK | Cuff, Tracheal Tube, Inflatable | 1 | 1 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
Plus 8 more product codes.
Review panels
Most recent Ventlab Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173373 | SafeT T-Piece Resuscitator | BTL | 2018-11-16 | 385 |
| K120118 | VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER | CAP | 2012-05-24 | 128 |
| K102674 | CUFF SENTRY | BSK | 2011-07-22 | 309 |
| K093617 | VENTLAB 6000 SERIES HUMIDIFIER | BTT | 2011-01-27 | 430 |
| K093525 | ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE | CCK | 2009-12-10 | 24 |
| K090840 | VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. | CAF | 2009-06-25 | 90 |
| K082204 | SERIES SY DISPOSABLE ELECTROSURGICAL PAD | ODR | 2008-08-13 | 8 |
| K063813 | VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA | CCK | 2008-03-26 | 460 |
| K040726 | VENTLAB NASAL CPAP CANNULA | BZD | 2004-06-03 | 73 |
| K030271 | VENTLAB BACTERIAL FILTER, MODEL BF100 | CAH | 2003-07-07 | 161 |
13 earlier clearances. See the full list in Caduvo.
Recalls
21 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2016-03-15.
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 Ventlab Corp. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Ventlab Corp.?
FDA lists 23 510(k) clearances under the applicant name “Ventlab Corp.” (first 1989, latest 2018), across 18 product codes in 3 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 Ventlab Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ventlab Corp. is 73 days.
Which FDA product codes appear under Ventlab Corp.?
The most frequent FDA product codes under this applicant name are BTM (Ventilator, Emergency, Manual (Resuscitator), 2); BZO (Set, Tubing And Support, Ventilator (W Harness), 2); CAF (Nebulizer (Direct Patient Interface), 2).
Next steps
- See all 23 Ventlab Corp. clearances with predicates and recalls
- Run predicate analysis for product code BTM, Ventlab Corp.'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.