Cleared Abbreviated

K010052 - RESPIRONICS BILICHEK NON-INVASIVE-100-0...

Also marketed or referenced as:
BILIRUBIN ANALYZER

K010052 is the FDA 510(k) clearance for RESPIRONICS BILICHEK NON-INVASIVE-100-0... by Respironics, Inc.. It is a Class 1 Chemistry device (product code MQM) cleared through the Abbreviated 510(k) pathway after a 70-day FDA review.

K010052 · Respironics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
70d
Days
Class 1
Risk

K010052 is an FDA 510(k) clearance for the RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20. Classified as Bilirubin (total And Unbound) In The Neonate Test System (product code MQM), Class I - General Controls.

Submitted by Respironics, Inc. (Kennesaw, US). The FDA issued a Cleared decision on March 19, 2001 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1113 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Respironics, Inc. devices

Submission Details

510(k) Number K010052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2001
Decision Date March 19, 2001
Days to Decision 70 days
Submission Type Abbreviated
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
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MQM Bilirubin (total And Unbound) In The Neonate Test System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1113
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 - MQM Bilirubin (total And Unbound) In The Neonate Test System

Devices cleared under the same product code (MQM) and FDA review panel - the closest regulatory comparables to K010052.
DRAEGER JAUNDICE METER JM-105
K133175 · Draeger Medical Systems, Inc. · Nov 2014
RAPIDPOINT 405 NEONATAL BILIRUBIN
K110277 · Siemens Healthcare Diagnostics · Aug 2011
BILIRUBIN ASSAY ON THE OMNI S ANALYZER
K040174 · Roche Diagnostics Corp. · May 2004
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
K983071 · Respironics, Inc. · Mar 1999
NBIL
K983134 · Abbott Laboratories · Sep 1998
IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES
K980646 · Instrumentation Laboratory CO · May 1998