510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863711Substantially Equivalent

Regulator Oxygen Mechanical

Lifeguard Medical Products, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863711 is the FDA 510(k) clearance record for REGULATOR OXYGEN MECHANICAL, a class I device, cleared for Lifeguard Medical Products, Inc. on under FDA product code CAN (Regulator, Pressure, Gas Cylinder). FDA records list 12 510(k) clearances for Lifeguard Medical Products, Inc., from to . As of , FDA records show no recalls naming K863711.

Clearance record

Decision date
Received
(126 days to decision)
Product code
CAN Regulator, Pressure, Gas Cylinder
Regulation
21 CFR 868.2700
Device class
Class I
Review panel
Anesthesiology
Applicant
Lifeguard Medical Products, Inc. 7476 Shadeland Station Way, Indianapolis IN
Third party review
No

Clearances, product code CAN

Trailing 12 months

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

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