Cleared Traditional

K954102 - SELECTMUCUS

K954102 is an FDA 510(k) clearance for SELECTMUCUS, manufactured by Select Medical Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFC cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K954102 · Select Medical Systems, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
82d
Days
Class 2
Risk

K954102 is an FDA 510(k) clearance for the SELECTMUCUS. Classified as Aspirator, Endocervical (product code HFC), Class II - Special Controls.

Submitted by Select Medical Systems, Inc. (Williston, US). The FDA issued a Cleared decision on November 21, 1995 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1050 - 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: 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 Select Medical Systems, Inc. devices

FDA 510(k) Submission Details - K954102

510(k) Number K954102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1995
Decision Date November 21, 1995
Days to Decision 82 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 160d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFC Device Classification - Class 2, Special Controls

Product Code HFC Aspirator, Endocervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1050
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 - HFC Aspirator, Endocervical

Devices cleared under the same product code (HFC) and FDA review panel - the closest regulatory comparables to K954102.
ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR
K974032 · A & A Medical, Inc. · Dec 1997
CERVICAL MUCOUS ASPIRATION CATHETER
K960263 · Cook Urological, Inc. · Aug 1996
PEDI VAGINAL ASPIRATOR
K954903 · Cook Urological, Inc. · Apr 1996
O. B. PACK IV
K902032 · Customed, Inc. · Sep 1990