Cleared Traditional

K992736 - WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM

K992736 is an FDA 510(k) clearance for WALLACH'S ULTIMATE REUSABLE, manufactured by Wallach Surgical Devices, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K992736 · Wallach Surgical Devices, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
47d
Days
Class 2
Risk

K992736 is an FDA 510(k) clearance for the WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Wallach Surgical Devices, Inc. (Orange, US). The FDA issued a Cleared decision on September 29, 1999 after a review of 47 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.

View all Wallach Surgical Devices, Inc. devices

FDA 510(k) Submission Details - K992736

510(k) Number K992736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1999
Decision Date September 29, 1999
Days to Decision 47 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
113d faster than avg
Panel avg: 160d · This submission: 47d
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 37
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K992736.
FEMSPEC DISPOSABLE VAGINAL SPECULUM
K041757 · Femspec LLC · Dec 2004
VAG O SPECULUM, MODELS VS1, VM1, VL1
K042950 · Panatrex, Inc. · Nov 2004
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL
K021676 · Cypress Medical Products, Ltd. · Jul 2002
PATTON SPECULUM
K991963 · Patton Medical Corp. · Sep 1999
GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043
K991827 · Ri Mos. S.R.L. · Jul 1999
VITALCARE DISPOSABLE VAGINAL SPECULUM
K983716 · Vitalcare Group, Inc. · Dec 1998