510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931607Substantially Equivalent

Meddrains

Armm, Inc., Huntington Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931607 is the FDA 510(k) clearance record for MEDDRAINS, a class I device, cleared for Armm, Inc. on under FDA product code GBN (Catheter, Pediatric, General & Plastic Surgery). FDA records list 4 510(k) clearances for Armm, Inc., from to . As of , FDA records show no recalls naming K931607.

Clearance record

Decision date
Received
(127 days to decision)
Product code
GBN Catheter, Pediatric, General & Plastic Surgery
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Armm, Inc. 17744 Sampson Ln., Huntington Beach CA
510(k) summary
Statement
Third party review
No

Clearances, product code GBN

Trailing 12 months

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

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