Cleared Traditional

K002912 - VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073

K002912 is an FDA 510(k) clearance for VAGINAL PORT, manufactured by Sterinc. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K002912 · Sterinc · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
156d
Days
Class 2
Risk

K002912 is an FDA 510(k) clearance for the VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Sterinc (Santa Ana, US). The FDA issued a Cleared decision on February 21, 2001 after a review of 156 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K002912

510(k) Number K002912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2000
Decision Date February 21, 2001
Days to Decision 156 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
5d faster than avg
Panel avg: 161d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIB Device Classification - Class 2, Special Controls

Product Code HIB Speculum, Vaginal, Nonmetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - HIB Speculum, Vaginal, Nonmetal

All 71
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K002912.
GLOBAL HEALTHCARE VAGINAL SPECULUM
K013835 · Dynascend Consulting Int'L, LLC · Jan 2002
GLO-SPEC
K013817 · Sol Weiss MD, Inc. · Dec 2001
NU-SPEC D
K012859 · Sol Weiss MD, Inc. · Oct 2001
(DISPOSABLE) VAGINAL SPECULUM
K003540 · Feminica, Inc. · Feb 2001
MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM
K000444 · Prism Enterprises, Inc. · Apr 2000
MEDISUL DISPOSABLE VAGINAL SPECULUM
K000414 · Marketing Perspectives · Apr 2000
K002912 · VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073
Download PDF FDA Summary Sterinc