Cleared Traditional

K882035 - HEART-CHILL SALINE SLUSH PAD

K882035 is an FDA 510(k) clearance for HEART-CHILL SALINE SLUSH PAD, manufactured by Buckman Co., Inc.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K882035 · Buckman Co., Inc. · Cardiovascular device
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Jul 1988
Decision
73d
Days
Class 2
Risk

K882035 is an FDA 510(k) clearance for the HEART-CHILL SALINE SLUSH PAD. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on July 28, 1988 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - the FDA cardiovascular device oversight 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 Buckman Co., Inc. devices

FDA 510(k) Submission Details - K882035

510(k) Number K882035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1988
Decision Date July 28, 1988
Days to Decision 73 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWJ Device Classification - Class 2, Special Controls

Product Code DWJ System, Thermal Regulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DWJ System, Thermal Regulating

All 117
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K882035.
BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION
K903360 · Augustine Medical, Inc. · Aug 1990
BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET
K900186 · Shiley, Inc. · Apr 1990
RK2000 K-THERMIA SYSTEM
K882442 · Baxter Healthcare Corp · Sep 1988
BAIR HUGGER(TM) - PATIENT WARMING SYSTEM
K873745 · Augustine Medical, Inc. · Nov 1987
THERMO-K
K820814 · American Medical Systems, Inc. · Apr 1982
MEDI-THERM
K800812 · Gaymar Industries, Inc. · Apr 1980