510(k) Report

FDA applicant

Cryomedical Instruments, Ltd.

Mansfield, GB1 decision2005–20050 recalls

FDA records 1 decision for Cryomedical Instruments, Ltd. (Mansfield, GB) in 2005: 1 510(k) clearance. All are in product code GXH (Device, Surgical, Cryogenic). Its devices cite 3 predicates, 0 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, neurology panel, where it files most

How often FDA has decided Cryomedical Instruments, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cryomedical Instruments, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cryomedical Instruments, Ltd.’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?

  • GXHDevice, Surgical, Cryogenic1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K050272Cryomedical Instruments Cryo-Pac SystemsCryomedical Instruments, Ltd. · 20051cites it

What has FDA decided for it lately?

  • K050272Cryomedical Instruments Cryo-Pac SystemsCryomedical Instruments, Ltd. · 2005

The one decision as Cryomedical Instruments, Ltd. →

Other applicant names beginning “Cryomedical”

FDA records each applicant name separately; these may or may not be the same firm.

Cryomedical Sciences, Inc. 10Cryomedical Instruemts, Ltd. 1