510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853124Substantially Equivalent

Novametrix Pulse Oximeter, Model 500

Novametrix Medical Systems, Inc., Wallingford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853124 is the FDA 510(k) clearance record for NOVAMETRIX PULSE OXIMETER, MODEL 500, a class II device, cleared for Novametrix Medical Systems, Inc. on under FDA product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic). FDA records list 45 510(k) clearances for Novametrix Medical Systems, Inc., from to . As of , FDA records show no recalls naming K853124.

Clearance record

Decision date
Received
(104 days to decision)
Product code
JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Regulation
21 CFR 870.2780
Device class
Class II
Review panel
Cardiovascular
Applicant
Novametrix Medical Systems, Inc. 1 Barnes Industrial Park Rd., Wallingford CT
Third party review
No

Clearances, product code JOM

Trailing 12 months

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

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