Cleared Traditional

K113216 - RAPIDPOINT 500 BLOOD GAS ANALYER

K113216 is an FDA 510(k) clearance for RAPIDPOINT 500 BLOOD GAS ANALYER, manufactured by Siemens Healthcare Diagnostics. The device is a Class 1 Chemistry device with product code KHP cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K113216 · Siemens Healthcare Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
184d
Days
Class 1
Risk

K113216 is an FDA 510(k) clearance for the RAPIDPOINT 500 BLOOD GAS ANALYER. Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by Siemens Healthcare Diagnostics (Norowood, US). The FDA issued a Cleared decision on May 3, 2012 after a review of 184 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1450 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K113216

510(k) Number K113216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2011
Decision Date May 03, 2012
Days to Decision 184 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 88d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

KHP Device Classification - Class 1, General Controls

Product Code KHP Acid, Lactic, Enzymatic Method
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1450
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KHP Acid, Lactic, Enzymatic Method

All 22
Devices cleared under the same product code (KHP) and FDA review panel - the closest regulatory comparables to K113216.
PICCOLO LACTATE TEST SYSTEM
K130113 · Abaxis, Inc. · Mar 2013
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
K112955 · Nova Biomedical Corporation · Jan 2012
I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
K112430 · Abbott Pont of Care, Inc. · Dec 2011
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
K100602 · Nova Biomedical Corp. · Aug 2011
EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
K093297 · Epocal, Inc. · Jun 2010
IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
K013938 · Diametrics Medical, Inc. · Jan 2002