Cleared Traditional

K840299 - PH ELECTRODE CALIBRATING BUFFERS-BLOOD

K840299 is an FDA 510(k) clearance for PH ELECTRODE CALIBRATING BUFFERS-BLOOD, manufactured by Bionostics, Inc.. The device is a Class 2 Chemistry device with product code JIS cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K840299 · Bionostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
59d
Days
Class 2
Risk

K840299 is an FDA 510(k) clearance for the PH ELECTRODE CALIBRATING BUFFERS-BLOOD. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Bionostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bionostics, Inc. devices

FDA 510(k) Submission Details - K840299

510(k) Number K840299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1984
Decision Date March 23, 1984
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIS Device Classification - Class 2, Special Controls

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIS Calibrator, Primary

All 112
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K840299.
DUPONT ACA MAGNESIUM CALIBRATOR
K841955 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1984
CHOLESTEROL AQUEOUS STANDARD
K840217 · Preventive Diagnostics Corp. · Mar 1984
HDL CHOLESTEROL AQUEOUS STANDARDS
K840220 · Preventive Diagnostics Corp. · Mar 1984
PRECISET CHOLESTEROL HIGH PERFORM
K832251 · Boehringer Mannheim Corp. · Aug 1983
LITHIUM DILUENT
K830283 · Shaban Mfg. Co. · Feb 1983
CALIBRATOR A
K830137 · Hi Chem, Inc. · Feb 1983