Cleared Traditional

K822197 - NEEDLE HOLDERS

K822197 is an FDA 510(k) clearance for NEEDLE HOLDERS, manufactured by Kelleher Corp.. The device is a Class 2 Toxicology device with product code LCR cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K822197 · Kelleher Corp. · Toxicology device
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Aug 1982
Decision
24d
Days
Class 2
Risk

K822197 is an FDA 510(k) clearance for the NEEDLE HOLDERS. Classified as Fluorescent Immunoassay, Tobramycin (product code LCR), Class II - Special Controls.

Submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1982 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3900 - 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: 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 Kelleher Corp. devices

FDA 510(k) Submission Details - K822197

510(k) Number K822197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1982
Decision Date August 16, 1982
Days to Decision 24 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
63d faster than avg
Panel avg: 87d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCR Device Classification - Class 2, Special Controls

Product Code LCR Fluorescent Immunoassay, Tobramycin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3900
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 Toxicology devices follow this clearance model.

Regulatory Peers - LCR Fluorescent Immunoassay, Tobramycin

All 15
Devices cleared under the same product code (LCR) and FDA review panel - the closest regulatory comparables to K822197.
INTRAOCULAR PRESSURE REDUCER
K854873 · Mira, Inc. · Feb 1986
DU PONT TOBRAMYCIN ASSAY REAGENTS
K850058 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1985
STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM
K832408 · American Dade · Aug 1983
VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA
K821542 · Electro-Nucleonics Laboratories, Inc. · Jun 1982
ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY
K820130 · Syva Co. · Feb 1982
TOBRAMYCIN FLUORESCENT IMMUNOASSAY
K813542 · American Diagnostic Corp. · Jan 1982