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
K921852Substantially Equivalent

4 Sure Tm Rectal Tube

Boston Pacific Medical, Inc., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921852 is the FDA 510(k) clearance record for 4 SURE TM RECTAL TUBE, a class I device, cleared for Boston Pacific Medical, Inc. on under FDA product code KMO (Binder, Elastic). FDA records list 11 510(k) clearances for Boston Pacific Medical, Inc., from to . As of , FDA records show no recalls naming K921852.

Clearance record

Decision date
Received
(539 days to decision)
Product code
KMO Binder, Elastic
Regulation
21 CFR 880.5160
Device class
Class I
Review panel
General Hospital
Applicant
Boston Pacific Medical, Inc. 636 Beacon St., Boston MA
510(k) summary
Statement
Third party review
No

Clearances, product code KMO

Trailing 12 months

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

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