510(k) Report

FDA applicant

Ncs Lab Srl

Carpi, MO4 decisions2012–20220 recalls

FDA records 4 decisions for Ncs Lab Srl (Carpi, MO) from 2012 to 2022: 4 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Since 2016 its 510(k)s took a median of 172 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 6 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, physical medicine panel, where it files most

How often FDA has decided Ncs Lab Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2012: 12016: 12021: 12022: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Ncs Lab Srl by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • IPFStimulator, Muscle, Powered2decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue2decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 172 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 98 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 2 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.

  • K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl · 20121cites it
  • K210674Shoulder PacemakerNcs Lab Srl · 20211cites it

What has FDA decided for it lately?

  • K220994Shoulder PacemakerTMNcs Lab Srl · 2022
  • K210674Shoulder PacemakerNcs Lab Srl · 2021
  • K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl · 2016
  • K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl · 2012

All 4 as Ncs Lab Srl →