510(k) Report

FDA applicant

Vascular Control Systems, Inc.

San Juan Capistrano, CA9 decisions2002–20060 recalls

FDA records 9 decisions for Vascular Control Systems, Inc. (San Juan Capistrano, CA) from 2002 to 2006: 9 510(k) clearances. Most are in product codes DXC (Clamp, Vascular) and HDC (Tenaculum, Uterine). Its devices cite 14 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Vascular Control Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vascular Control Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vascular Control Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vascular Control Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DXCClamp, Vascular4decisions
  • HDCTenaculum, Uterine2decisions
  • ITXTransducer, Ultrasonic, Diagnostic2decisions
  • DPWFlowmeter, Blood, Cardiovascular1decision

Whose devices does it build on?

Its devices cite 14 predicates; 5 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K023024Transvaginal Doppler Probe, Model 09-0006-02Vascular Control Systems, Inc. · 20022cite it
  • K011863VCS-a Series ClampVascular Control Systems, Inc. · 20021cites it
  • K030078Burbank Tenaculum, Model 09-0011-01Vascular Control Systems, Inc. · 20031cites it
  • K023154VCS-a Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02Vascular Control Systems, Inc. · 20021cites it

What has FDA decided for it lately?

  • K060573Burbank TenaculumVascular Control Systems, Inc. · 2006
  • K052209VCS Doppler Transceiver, Model 09-0023-01Vascular Control Systems, Inc. · 2005
  • K032125Cstat, Models 09-0014-01 and 09-0014-02Vascular Control Systems, Inc. · 2004
  • K031812Transvaginal Doppler Clamp, Models: 09-0016-01, 09-0016-02, 09-0016-03Vascular Control Systems, Inc. · 2003
  • K031358Transvaginal Doppler ProbeVascular Control Systems, Inc. · 2003
  • K030078Burbank Tenaculum, Model 09-0011-01Vascular Control Systems, Inc. · 2003
  • K023154VCS-a Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02Vascular Control Systems, Inc. · 2002
  • K023024Transvaginal Doppler Probe, Model 09-0006-02Vascular Control Systems, Inc. · 2002

All 9 as Vascular Control Systems, Inc. →