Cleared Traditional

K920970 - BACTIDROP KOH (10%)

K920970 is an FDA 510(k) clearance for BACTIDROP KOH (10%), manufactured by Remel Co.. The device is a Class 1 Pathology device with product code JTS cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K920970 · Remel Co. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
99d
Days
Class 1
Risk

K920970 is an FDA 510(k) clearance for the BACTIDROP KOH (10%). Classified as Stains, Microbiologic (product code JTS), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on June 9, 1992 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1850 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Remel Co. devices

FDA 510(k) Submission Details - K920970

510(k) Number K920970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1992
Decision Date June 09, 1992
Days to Decision 99 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 77d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

JTS Device Classification - Class 1, General Controls

Product Code JTS Stains, Microbiologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
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 - JTS Stains, Microbiologic

All 33
Devices cleared under the same product code (JTS) and FDA review panel - the closest regulatory comparables to K920970.
CALCOFLUOR WHITE STAIN KIT
K960090 · Remel Co. · Mar 1996
BACTIDROP CALCOFLUOR WHITE
K960095 · Remel Co. · Mar 1996
BACTIDROP CALCOFLUOR WHITE
K920975 · Remel Co. · Jun 1992
BACTIDROP INDIA INK
K920976 · Remel Co. · Jun 1992
ATS DOBELL & O'CONNOR'S IODINE
K890861 · Alpha-Tec Systems, Inc. · Mar 1989
ATS LUGOL'S IODINE SOLUTION
K890020 · Alpha-Tec Systems, Inc. · Feb 1989