Cleared Traditional

K931205 - MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER

K931205 is an FDA 510(k) clearance for MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER, manufactured by Baxter Healthcare Corp. The device is a Class 2 Obstetrics & Gynecology device with product code HHI cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K931205 · Baxter Healthcare Corp · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
371d
Days
Class 2
Risk

K931205 is an FDA 510(k) clearance for the MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER. Classified as System, Abortion, Vacuum (product code HHI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Deerfield, US). The FDA issued a Cleared decision on March 15, 1994 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5070 - the FDA obstetrics and gynecology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K931205

510(k) Number K931205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1993
Decision Date March 15, 1994
Days to Decision 371 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 160d · This submission: 371d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHI Device Classification - Class 2, Special Controls

Product Code HHI System, Abortion, Vacuum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5070
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HHI System, Abortion, Vacuum

Devices cleared under the same product code (HHI) and FDA review panel - the closest regulatory comparables to K931205.
Berkeley VC-10 Vacuum Curettage System
K171440 · Gyrus Acmi · Sep 2017
BERKELEY V-10 VACUUM CURETTAGE SYSTEM
K030935 · Acmi Corporation · Jun 2003
CYTOPREP
K983181 · Cytoprep Inc. Est. · Nov 1998
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
K880734 · Personal Products Co. · Apr 1988
GYNASPYR VACUUM CURETTAGE UNIT
K850312 · Roseburg SA · Feb 1985
UTERINE VACUM ASPIRATING CURRETTE
K802360 · American Hospital Supply Corp. · Oct 1980