510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K040632Substantially Equivalent

Snuggle Warm 4000 Convective Warming System, Model Sw4000

Abbott Medical, Rockland MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040632 is the FDA 510(k) clearance record for SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000, a class II device, cleared for Smiths Medical Asd, Inc. on under FDA product code DWJ (System, Thermal Regulating). FDA's definition for product code DWJ reads: "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...". FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show one recall naming K040632.

Clearance record

Decision date
Received
(48 days to decision)
Product code
DWJ System, Thermal Regulating
Regulation
21 CFR 870.5900
Device class
Class II
Review panel
Cardiovascular
Applicant
Smiths Medical Asd, Inc. 160 Weymouth St., Rockland MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWJ

Trailing 12 months
5 clearances under product code DWJ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20261
August 20262
September 20260
October 20260