510(k) Report

FDA applicant

Somavac Medical Solutions, Inc.

Bartlett, TN3 decisions2018–20230 recalls

FDA records 3 decisions for Somavac Medical Solutions, Inc. (Bartlett, TN) from 2018 to 2023: 3 510(k) clearances. All are in product code BTA (Pump, Portable, Aspiration (Manual Or Powered)). Since 2016 its 510(k)s took a median of 28 days from receipt to decision, against 125 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 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, general and plastic surgery panel, where it files most

How often FDA has decided Somavac Medical Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2018: 12022: 12023: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Somavac Medical Solutions, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Somavac Medical Solutions, 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?

  • BTAPump, Portable, Aspiration (Manual Or Powered)3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 28 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 125 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K222856SOMAVAC 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. · 20222cite it
  • K180606SOMAVAC DeviceSomavac Medical Solutions, Inc. · 20181cites it

What has FDA decided for it lately?

  • K231063SOMAVAC® 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. · 2023
  • K222856SOMAVAC 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. · 2022
  • K180606SOMAVAC DeviceSomavac Medical Solutions, Inc. · 2018

All 3 as Somavac Medical Solutions, Inc. →