510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881969Substantially Equivalent

Dry Comfort Disposable Underpad

Health Tec, Inc., Palmer MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881969 is the FDA 510(k) clearance record for DRY COMFORT DISPOSABLE UNDERPAD, a class I device, cleared for Health Tec, Inc. on under FDA product code KME (Bedding, Disposable, Medical). FDA records list 2 510(k) clearances for Health Tec, Inc., from to . As of , FDA records show no recalls naming K881969.

Clearance record

Decision date
Received
(27 days to decision)
Product code
KME Bedding, Disposable, Medical
Regulation
21 CFR 880.6060
Device class
Class I
Review panel
General Hospital
Applicant
Health Tec, Inc. First St., Palmer MA
Third party review
No

Clearances, product code KME

Trailing 12 months

FDA records hold no clearances under product code KME in the trailing twelve months.

FDA records show no clearances under product code KME in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KME, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260