Cleared Traditional

K852790 - ANALYZER: NOVA STAT PROFILE 1 QUA CON M...

K852790 is the FDA 510(k) clearance for ANALYZER: NOVA STAT PROFILE 1 QUA CON M... by Nova Biomedical Corp.. It is a Class 2 Hematology device (product code CHL) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K852790 · Nova Biomedical Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
134d
Days
Class 2
Risk

K852790 is an FDA 510(k) clearance for the ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on November 12, 1985 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1120 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nova Biomedical Corp. devices

Submission Details

510(k) Number K852790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1985
Decision Date November 12, 1985
Days to Decision 134 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 113d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Hematology devices follow this clearance model.

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

All 107
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K852790.
ABL330 ACID BASE LABORATORY
K860057 · Radiometer America, Inc. · Mar 1986
LIFE WATCH RESPIRATORY MONITOR
K853840 · The Perkin-Elmer Corp. · Dec 1985
ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT.
K854608 · Nova Biomedical Corp. · Dec 1985
ABL300 ACID BASE LABORATORY
K844295 · Radiometer America, Inc. · Dec 1984
POTASSIUM CHLORIDE TABLETS
K840843 · Bionostics, Inc. · Apr 1984
FLUSH SOLUTION CONCENTRATE-BLOOD GAS
K840300 · Bionostics, Inc. · Mar 1984