Cleared Traditional

K810693 - CURITY PERINEAL COLD PACK

K810693 is an FDA 510(k) clearance for CURITY PERINEAL COLD PACK, manufactured by The Kendal Co.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810693 · The Kendal Co. · Physical Medicine device
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Mar 1981
Decision
13d
Days
Class 1
Risk

K810693 is an FDA 510(k) clearance for the CURITY PERINEAL COLD PACK. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by The Kendal Co. (Walker, US). The FDA issued a Cleared decision on March 26, 1981 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Kendal Co. devices

FDA 510(k) Submission Details - K810693

510(k) Number K810693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1981
Decision Date March 26, 1981
Days to Decision 13 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

IMD Device Classification - Class 1, General Controls

Product Code IMD Pack, Hot Or Cold, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5710
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IMD Pack, Hot Or Cold, Disposable

All 20
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K810693.
ACE BRAND INSTANT COLD PACK
K820282 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1982
BK-7182 INSTANT COLD PACK
K813628 · Fred Sammons, Inc. · Jan 1982
CURITY PERINEAL WARM PACK
K810692 · The Kendal Co. · Mar 1981
COLD PACK
K780603 · Abco Dealers, Inc. · Apr 1978
MUL-T-PAD
K760706 · Gaymar Industries, Inc. · Oct 1976