Imperative Care, Inc.: FDA filings under this applicant name

FDA lists 18 510(k) clearances under the applicant name “Imperative Care, Inc.” (first 2018, latest 2026), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 68 days. Since 2017 the median was 68 days, against 108 days for all cleared 510(k)s in the same product codes. 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Imperative Care, Inc. took a median 68 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.

Top product codes

Review panels

• Neurology (14)
• Cardiovascular (4)

Most recent Imperative Care, Inc. 510(k) clearances

8 earlier clearances. See the full list in Caduvo.

Recalls

1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-08-13.

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.

Device clinical trials

An industry sponsor named Imperative Care, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:

• NCT07491952: Continuous Dual Aspiration Technique With Zoom System for Stroke (Recruiting, started 2026-03-24)
• NCT07350499: Aspiration Thrombectomy Using the Symphony or Prodigy System (Recruiting, started 2026-02-13)
• NCT06062329: SYMPHONY-PE Study for Treatment of Pulmonary Embolism (Completed, started 2023-12-13)
• NCT04129125: The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System (Completed, started 2021-10-01)

Frequently asked questions

How many FDA 510(k) clearances are listed under Imperative Care, Inc.?

FDA lists 18 510(k) clearances under the applicant name “Imperative Care, Inc.” (first 2018, latest 2026), across 6 product codes in 2 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 Imperative Care, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Imperative Care, Inc. is 68 days. Since 2017: 68 days, versus 108 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Imperative Care, Inc.?

The most frequent FDA product codes under this applicant name are NRY (Catheter, Thrombus Retriever, 7); QJP (Catheter, Percutaneous, Neurovasculature, 6); QEW (Peripheral Mechanical Thrombectomy With Aspiration, 2).

Next steps

• See all 18 Imperative Care, Inc. clearances with predicates and recalls
• Run predicate analysis for product code NRY, Imperative Care, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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