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
K980287Substantially Equivalent

Siemens Sc9000/sc9015 Tcp02/c02 Module

Siemens Medical Solutions USA, Inc., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980287 is the FDA 510(k) clearance record for SIEMENS SC9000/SC9015 TCP02/C02 MODULE, a class II device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia). FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K980287.

Clearance record

Decision date
Received
(198 days to decision)
Product code
KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Regulation
21 CFR 868.2500
Device class
Class II
Review panel
Anesthesiology
Applicant
Siemens Medical Solutions USA, Inc. 16 Electronics Ave., Danvers MA
510(k) summary
Summary
Third party review
No

Clearances, product code KLK

Trailing 12 months

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

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