Cleared Traditional

K982928 - NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETR...

K982928 is an FDA 510(k) clearance for NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETR..., manufactured by Radiometer America, Inc.. The device is a Class 2 Chemistry device with product code CHL cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K982928 · Radiometer America, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
139d
Days
Class 2
Risk

K982928 is an FDA 510(k) clearance for the NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on January 6, 1999 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - 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 Radiometer America, Inc. devices

FDA 510(k) Submission Details - K982928

510(k) Number K982928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1998
Decision Date January 06, 1999
Days to Decision 139 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 88d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHL Device Classification - Class 2, Special Controls

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 151
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K982928.
ABL 735 ANALYZER
K991417 · Radiometer America, Inc. · Nov 1999
GEM PREMIER 3000
K992834 · Instrumentation Laboratory CO · Nov 1999
AVL OMNI MODULAR ANALYZER
K990092 · Avl Scientific Corp. · Jan 1999
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
K982277 · Nova Biomedical Corp. · Jul 1998
NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
K980991 · Nova Biomedical Corp. · Apr 1998
ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
K980130 · Radiometer America, Inc. · Feb 1998