Cleared Traditional

K910180 - BACTI-SWAB

K910180 is the FDA 510(k) clearance for BACTI-SWAB by Remel Co.. It is a Class 1 Microbiology device (product code JSM) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K910180 · Remel Co. · Microbiology device
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May 1991
Decision
115d
Days
Class 1
Risk

K910180 is an FDA 510(k) clearance for the BACTI-SWAB. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on May 10, 1991 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Remel Co. devices

Submission Details

510(k) Number K910180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1991
Decision Date May 10, 1991
Days to Decision 115 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 102d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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 - JSM Culture Media, Non-propagating Transport

All 49
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K910180.
CVM TRANSPORT
K955451 · Hardy Diagnostics · Jul 1996
FLEXTRANS
K935987 · Baxter Diagnostics, Inc. · Aug 1994
AEROBIC FOAM SWAB CULTURETTE(R)
K913789 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
CARY AND BLAIR TRANSPORT MEDIUM
K881529 · Acumedia Manufacturers, Inc. · Apr 1988
AMIES TRANSPORT MEDIUM
K881539 · Acumedia Manufacturers, Inc. · Apr 1988
STUARTS TRANSPORT MEDIUM
K881569 · Acumedia Manufacturers, Inc. · Apr 1988