Cleared Traditional

K910180 - BACTI-SWAB

K910180 is an FDA 510(k) clearance for BACTI-SWAB, manufactured by Remel Co.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K910180

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.

JSM Device Classification - Class 1, General Controls

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 77
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
SAF FECAL COLLECTION KIT
K885244 · Precision Biologicals, Inc. · Mar 1989
CARY-BLAIR TRANSPORT SYSTEM
K885245 · Precision Biologicals, Inc. · Mar 1989
CARY AND BLAIR TRANSPORT MEDIUM
K881529 · Acumedia Manufacturers, Inc. · Apr 1988