510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K914207Substantially Equivalent

Clearsite(r) Sterile Wound Care Dressing

Ndm Acquisition Corp., Dayton OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914207 is the FDA 510(k) clearance record for CLEARSITE(R) STERILE WOUND CARE DRESSING, a class I device, cleared for Ndm Acquisition Corp. on under FDA product code NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic). FDA records list 4 510(k) clearances for Ndm Acquisition Corp., from to . As of , FDA records show no recalls naming K914207.

Clearance record

Decision date
Received
(34 days to decision)
Product code
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Regulation
21 CFR 878.4022
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Ndm Acquisition Corp. P.O. Box 1408, Dayton OH
510(k) summary
Statement
Third party review
No

Clearances, product code NAE

Trailing 12 months

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

FDA records show no clearances under product code NAE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NAE, 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