Cleared Traditional

K000444 - MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM

K000444 is an FDA 510(k) clearance for MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM, manufactured by Prism Enterprises, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K000444 · Prism Enterprises, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
71d
Days
Class 2
Risk

K000444 is an FDA 510(k) clearance for the MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Prism Enterprises, Inc. (San Antonio, US). The FDA issued a Cleared decision on April 21, 2000 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K000444

510(k) Number K000444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2000
Decision Date April 21, 2000
Days to Decision 71 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
90d faster than avg
Panel avg: 161d · This submission: 71d
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 K000444.
NU-SPEC D
K012859 · Sol Weiss MD, Inc. · Oct 2001
VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073
K002912 · Sterinc · Feb 2001
(DISPOSABLE) VAGINAL SPECULUM
K003540 · Feminica, Inc. · Feb 2001
MEDISUL DISPOSABLE VAGINAL SPECULUM
K000414 · Marketing Perspectives · Apr 2000
WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
K992736 · Wallach Surgical Devices, Inc. · Sep 1999
PATTON SPECULUM
K991963 · Patton Medical Corp. · Sep 1999
K000444 · MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM
Download PDF FDA Summary Prism Enterprises, In…