510(k) Report

FDA applicant

Cryogen, Inc.

San Diego, CA4 decisions1997–20000 recalls

FDA records 4 decisions for Cryogen, Inc. (San Diego, CA) from 1997 to 2000: 4 510(k) clearances. Most are in product codes GEH (Unit, Cryosurgical, Accessories) and OCL (Surgical Device, For Cutting, Coagulation…). Its devices cite 8 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 Cryogen, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cryogen, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cryogen, Inc.’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?

  • GEHUnit, Cryosurgical, Accessories2decisions
  • OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac…1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 19983cite it
  • K972662Cryogen Cryosurgical SystemCryogen, Inc. · 19971cites it
  • K003050Cryosurgical Unit and AccessoriesCryogen, Inc. · 20001cites it
  • K964971Cryogen Cryosurgical SystemCryogen, Inc. · 19971cites it

What has FDA decided for it lately?

  • K003050Cryosurgical Unit and AccessoriesCryogen, Inc. · 2000
  • K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
  • K972662Cryogen Cryosurgical SystemCryogen, Inc. · 1997
  • K964971Cryogen Cryosurgical SystemCryogen, Inc. · 1997

All 4 as Cryogen, Inc. →