Cleared Traditional

K071126 - CRYOSEAL FS APPLICATOR SYSTEM

K071126 is an FDA 510(k) clearance for CRYOSEAL FS APPLICATOR SYSTEM, manufactured by Thermogenesis Corp.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K071126 · Thermogenesis Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
115d
Days
Class 2
Risk

K071126 is an FDA 510(k) clearance for the CRYOSEAL FS APPLICATOR SYSTEM. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Thermogenesis Corp. (Rancho Cordova, US). The FDA issued a Cleared decision on August 16, 2007 after a review of 115 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Thermogenesis Corp. devices

FDA 510(k) Submission Details - K071126

510(k) Number K071126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2007
Decision Date August 16, 2007
Days to Decision 115 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 129d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 483
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K071126.
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
K072330 · Biomet, Inc. · Dec 2007
ICU MEDICAL SINGLE-USE SYRINGE
K070856 · Icu Medical, Inc. · Oct 2007
SMALL VOLUME SYRINGE
K062865 · Alcon Laboratories · Aug 2007
B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
K071459 · B.Braun Medical, Inc. · Aug 2007
TERUMO 31G THINPRO INSULIN SYRINGE
K071630 · Terumo Medical Corp. · Jul 2007
GENIE, MODEL CH-200
K070633 · Icu Medical, Inc. · Jun 2007