510(k) Report

FDA applicant

Cryoconcepts LP

Bethlehem, PA8 decisions2017–20250 recalls

FDA records 8 decisions for Cryoconcepts LP (Bethlehem, PA) from 2017 to 2025: 8 510(k) clearances. All are in product code GEH (Unit, Cryosurgical, Accessories). Since 2016 its 510(k)s took a median of 96 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 9 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 Cryoconcepts LP’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2017: 12019: 22022: 12024: 22025: 2
2017high 2 (2019) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Cryoconcepts LP by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cryoconcepts LP’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?

  • GEHUnit, Cryosurgical, Accessories8decisions

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 96 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 84 days; 5 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 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.

  • K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 20227cite it
  • K190407CryoLabCryoconcepts LP · 20191cites it
  • K172769CryOmega FlexxCryoconcepts LP · 20171cites it
  • K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 20251cites it

What has FDA decided for it lately?

  • K251493Skin Clinic Freeze Point for Warts and Skin TagsCryoconcepts LP · 2025
  • K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025
  • K242625Freeze Point & Private Label VersionsCryoconcepts LP · 2024
  • K240106Histofreezer VCryoconcepts LP · 2024
  • K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 2022
  • K190407CryoLabCryoconcepts LP · 2019
  • K183601CryoTouchCryoconcepts LP · 2019
  • K172769CryOmega FlexxCryoconcepts LP · 2017

All 8 as Cryoconcepts LP →