Cleared Traditional

K930634 - SUR FLO THERMAL THERAPY PADS

K930634 is the FDA 510(k) clearance for SUR FLO THERMAL THERAPY PADS by Buckman Co., Inc.. It is a Class 2 Physical Medicine device (product code ILO) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K930634 · Buckman Co., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
266d
Days
Class 2
Risk

K930634 is an FDA 510(k) clearance for the SUR FLO THERMAL THERAPY PADS. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on November 1, 1993 after a review of 266 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5720 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Buckman Co., Inc. devices

Submission Details

510(k) Number K930634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1993
Decision Date November 01, 1993
Days to Decision 266 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 115d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ILO Pack, Hot Or Cold, Water Circulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5720
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ILO Pack, Hot Or Cold, Water Circulating

All 21
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K930634.
EBICE
K945067 · Electro-Biology, Inc. · Feb 1995
INCARE HOT/ICE COLD THERAPY COOLER
K944971 · Hollister, Inc. · Jan 1995
HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS
K931843 · Hollister, Inc. · Feb 1994
MEDICOOL
K923643 · Micromedic Systems · Mar 1993
INCARE HOT/ICE SYSTEM 3
K915196 · Hollister, Inc. · Feb 1992
HYPER-K HEAT SYSTEM
K912722 · Baxter Healthcare Corp · Sep 1991