510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113216Substantially Equivalent

Rapidpoint 500 Blood Gas Analyer

Siemens Healthcare Diagnostics Inc., Norowood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113216 is the FDA 510(k) clearance record for RAPIDPOINT 500 BLOOD GAS ANALYER, a class I device, cleared for Siemens Healthcare Diagnostics on under FDA product code KHP (Acid, Lactic, Enzymatic Method). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, from to . As of , FDA records show 12 recalls naming K113216.

Clearance record

Decision date
Received
(184 days to decision)
Product code
KHP Acid, Lactic, Enzymatic Method
Regulation
21 CFR 862.1450
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Siemens Healthcare Diagnostics 2 Edgewater Dr., Norowood MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KHP

Trailing 12 months

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

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