Cleared Traditional

K831387 - HS-100 HEADSPACE SAMPLING ACCESSORY

K831387 is an FDA 510(k) clearance for HS-100 HEADSPACE SAMPLING ACCESSORY, manufactured by The Perkin-Elmer Corp.. The device is a Class 1 Toxicology device with product code KZQ cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K831387 · The Perkin-Elmer Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1983
Decision
118d
Days
Class 1
Risk

K831387 is an FDA 510(k) clearance for the HS-100 HEADSPACE SAMPLING ACCESSORY. Classified as Chromatography(gas), Clinical Use (product code KZQ), Class I - General Controls.

Submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1983 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2250 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all The Perkin-Elmer Corp. devices

FDA 510(k) Submission Details - K831387

510(k) Number K831387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1983
Decision Date August 24, 1983
Days to Decision 118 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 87d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

KZQ Device Classification - Class 1, General Controls

Product Code KZQ Chromatography(gas), Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2250
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 - KZQ Chromatography(gas), Clinical Use

All 9
Devices cleared under the same product code (KZQ) and FDA review panel - the closest regulatory comparables to K831387.
8000 SERIES GAS CHROMATOGRAPHS
K872122 · The Perkin-Elmer Corp. · Jun 1987
VARIAN 3300 & 3400 GAS CHROMATOGRAPHS
K841891 · Varian Assoc., Inc. · Jul 1984
GAS CHROMATOGRAPH 5890A
K832962 · Hewlett-Packard Co. · Oct 1983
SIGMA 300 GAS CHROMATROGRAPH
K830147 · The Perkin-Elmer Corp. · Feb 1983
SIGMA 2000 GAS CHROMATOGRAPH
K820283 · The Perkin-Elmer Corp. · Feb 1982
MODEL 5790 GAS CHROMATOGRAPH
K820071 · Hewlett-Packard Co. · Jan 1982