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
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K841605Substantially Equivalent

Bp Trauma Air Pants

Bp Medical Systems, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841605 is the FDA 510(k) clearance record for BP TRAUMA AIR PANTS, a class II device, cleared for Bp Medical Systems, Inc. on under FDA product code LHX (Trousers, Anti-Shock). FDA records list one 510(k) clearance for Bp Medical Systems, Inc. As of , FDA records show no recalls naming K841605.

Clearance record

Decision date
Received
(78 days to decision)
Product code
LHX Trousers, Anti-Shock
Regulation
21 CFR 870.5800
Device class
Class II
Review panel
Cardiovascular
Applicant
Bp Medical Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LHX

Trailing 12 months

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

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