# Imperative Care, Inc.

- Location (FDA's records): Campbell, CA
- FDA decisions: 18 (2018–2026): 18 510(k) clearances
- Product codes: NRY (7), QJP (6), QEW (2), MOF (1), DQY (1), DQO (1)
- 510(k) review time since 2016: median 68 days, against 129 for FDA's reviews in the same codes and years (11 of 18 faster)
- Predicates its devices cite: 22 (13 its own); citations of its devices by later devices: 21 (13 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Scientia Vascular, LLC: 2 (https://510kreport.com/company/scientia-vascular)
- Inneuroco, Inc.: 1 (https://510kreport.com/company/inneuroco)
- Truvic Medical, Inc.: 1 (https://510kreport.com/company/truvic-medical)
- Penumbra, Inc.: 1 (https://510kreport.com/company/penumbra)
- Micro Therapeutics Dba Ev3 Neurovascular: 1 (https://510kreport.com/company/micro-therapeutics-dba-ev3-neurovascular)
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular: 1 (https://510kreport.com/company/micro-therapeutics-d-b-a-ev3-neurovascular)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)
- Stryker Neurovascular: 1 (https://510kreport.com/company/stryker-neurovascular)

## Firms that cite its devices most
- Balt USA, LLC: 2 (https://510kreport.com/company/balt-usa)
- Cerenovus, Inc.: 1 (https://510kreport.com/company/cerenovus)
- Toro Neurovascular, Inc.: 1 (https://510kreport.com/company/toro-neurovascular)
- Route 92 Medical, Inc.: 1 (https://510kreport.com/company/route-92-medical)
- Perfuze, Ltd.: 1 (https://510kreport.com/company/perfuze)
- Piraeus Medical: 1 (https://510kreport.com/company/piraeus-medical)
- Jupiter Endovascular: 1 (https://510kreport.com/company/jupiter-endovascular)

## Its most-cited devices
- K211476: ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing (2021), cited by 3
- K210996: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing (2021), cited by 3
- K180169: EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length (2018), cited by 3
- K212224: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform (2021), cited by 3
- K203764: TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform (2021), cited by 3
- K183043: 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter (2019), cited by 1

## Recent decisions
- K261176: Zoom 4S Catheter (Aug 28, 2026)
- K252046: Zoom System (Zoom 4S Catheter) (Oct 30, 2025)
- K252057: Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System (Aug 28, 2025)
- K244061: X-Wire Guidewire (Aug 26, 2025)
- K243047: Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (May 28, 2025)
- K250775: Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System (May 14, 2025)
- K242672: Zoom System (Jan 14, 2025)
- K240948: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support (Jun 6, 2024)

Source page: https://510kreport.com/company/imperative-care