Cleared Traditional

K012859 - NU-SPEC D

K012859 is an FDA 510(k) clearance for NU-SPEC D, manufactured by Sol Weiss MD, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K012859 · Sol Weiss MD, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
63d
Days
Class 2
Risk

K012859 is an FDA 510(k) clearance for the NU-SPEC D. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Sol Weiss MD, Inc. (Reseda, US). The FDA issued a Cleared decision on October 26, 2001 after a review of 63 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 - K012859

510(k) Number K012859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2001
Decision Date October 26, 2001
Days to Decision 63 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
98d faster than avg
Panel avg: 161d · This submission: 63d
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 K012859.
DRG DISPOSABLE VAGINAL SPECULUM
K012535 · Doctor'S Research Group, Inc. · Mar 2002
GLOBAL HEALTHCARE VAGINAL SPECULUM
K013835 · Dynascend Consulting Int'L, LLC · Jan 2002
GLO-SPEC
K013817 · Sol Weiss MD, Inc. · Dec 2001
VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073
K002912 · Sterinc · Feb 2001
(DISPOSABLE) VAGINAL SPECULUM
K003540 · Feminica, Inc. · Feb 2001
MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM
K000444 · Prism Enterprises, Inc. · Apr 2000
K012859 · NU-SPEC D
Download PDF FDA Summary Sol Weiss MD, Inc.