Vapotherm, Inc.: FDA clearances and approvals

Vapotherm, Inc. has 12 FDA 510(k) clearances (first 2000, latest 2026), plus 1 De Novo decision, across 3 product codes in 1 review panel. Median 510(k) review time: 188 days. Since 2017 its median was 217 days, against 239 days for all cleared 510(k)s in the same product codes. openFDA lists 10 product recalls by a recalling firm named Vapotherm, Inc. It is the industry lead sponsor of 6 device clinical trials on ClinicalTrials.gov.

510(k) clearances per year

Review time against the same product codes

Since 2017, Vapotherm, Inc.'s cleared 510(k)s took a median 217 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 239 days.

Top product codes

Review panels

• Anesthesiology (13)

Most recent Vapotherm, Inc. 510(k) clearances

2 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

10 product recalls in 3 recall events; 1 initiated in the last five years. Most recent: 2022-12-16.

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

Vapotherm, Inc. is the industry lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT05984186: Effect of High Velocity/Hyperoxic Breathing Therapy on Blood Lactate Decline (Completed, started 2023-03-06)
• NCT04709562: Clinical Stabilization of Hypercapnia: NIPPV v HVNI (Completed, started 2020-11-11)
• NCT04512781: Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs (Completed, started 2020-10-01)
• NCT03885726: HVNI Ambulation Feasibility Study (Completed, started 2018-11-21)
• NCT02074774: IntellO2 vs Manual Control for Optimizing Oxygenation in Infants (Completed, started 2016-12)

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of Vapotherm, Inc.'s product codes (a text match, not an official crosswalk):

• G0379 — Direct admission of patient for hospital observation care (via CAF)

Frequently asked questions

How many FDA 510(k) clearances does Vapotherm, Inc. have?

Vapotherm, Inc. has 12 FDA 510(k) clearances (first 2000, latest 2026), plus 1 De Novo decision, across 3 product codes in 1 review panel.

How long does FDA take to clear Vapotherm, Inc.'s 510(k)s?

The median time from FDA receipt to decision across Vapotherm, Inc.'s cleared 510(k)s is 188 days. Since 2017: 217 days, versus 239 days for all cleared 510(k)s in the same product codes.

What devices does Vapotherm, Inc. make?

Its most frequent FDA product codes are BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 10); QAV (High Flow/High Velocity Humidified Oxygen Delivery Device, 2); CAF (Nebulizer (Direct Patient Interface), 1).

Has Vapotherm, Inc. had device recalls?

openFDA lists 10 product recalls in 3 recall events by a recalling firm whose name matches Vapotherm, Inc; the most recent began 2022-12-16. Recall firm names are matched by name, so related entities filing under other names are not included.

Next steps

• See all 12 Vapotherm, Inc. clearances with predicates and recalls
• Run predicate analysis for product code BTT, Vapotherm, Inc.'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.

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