510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862426Substantially Equivalent

Pulse Oximeter

Draeger, Inc., Telford PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862426 is the FDA 510(k) clearance record for PULSE OXIMETER, a class II device, cleared for Draeger Medical, Inc. on under FDA product code DPZ (Oximeter, Ear). FDA records list 84 510(k) clearances for DRAEGER, INC., from to . As of , FDA records show no recalls naming K862426.

Clearance record

Decision date
Received
(77 days to decision)
Product code
DPZ Oximeter, Ear
Regulation
21 CFR 870.2710
Device class
Class II
Review panel
Cardiovascular
Applicant
Draeger Medical, Inc. 148 B. Quarry Rd., Telford PA
Third party review
No

Clearances, product code DPZ

Trailing 12 months

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

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