Cleared Traditional

K831017 - BUFFER PACK FOR ABL-1 & ABL-2

K831017 is the FDA 510(k) clearance for BUFFER PACK FOR ABL-1 & ABL-2 by Fisher Scientific Co., LLC. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K831017 · Fisher Scientific Co., LLC · Chemistry device
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May 1983
Decision
40d
Days
Class 2
Risk

K831017 is an FDA 510(k) clearance for the BUFFER PACK FOR ABL-1 & ABL-2. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 40 days - a notably fast clearance cycle.

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: 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 Fisher Scientific Co., LLC devices

Submission Details

510(k) Number K831017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1983
Decision Date May 09, 1983
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
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 Chemistry devices follow this clearance model.

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

All 118
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K831017.
DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON
K831012 · Fisher Scientific Co., LLC · Jun 1983
DIAGNOSTICS PO 2 ELECTROLYTE
K831013 · Fisher Scientific Co., LLC · Jun 1983
DIAGNOSTICS PH ELECTRODE CLEANING SOLUT
K831015 · Fisher Scientific Co., LLC · May 1983
FLUSH SOLUTION CONCENTRATE
K831020 · Fisher Scientific Co., LLC · May 1983
DIAGNOSTICS PO2 ELECTRODE CLEANER
K831010 · Fisher Scientific Co., LLC · May 1983
BATH CLEAR
K831016 · Fisher Scientific Co., LLC · May 1983