Cleared Traditional

K091937 - OFFICE-SPEC DISPOSABLE SIDE-OPENING SPE...

K091937 is an FDA 510(k) clearance for OFFICE-SPEC DISPOSABLE SIDE-OPENING SPE..., manufactured by Obp Corporation. 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.

K091937 · Obp Corporation · Obstetrics & Gynecology device
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Sep 2009
Decision
71d
Days
Class 2
Risk

K091937 is an FDA 510(k) clearance for the OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Obp Corporation (Lawerence, US). The FDA issued a Cleared decision on September 9, 2009 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.

View all Obp Corporation devices

FDA 510(k) Submission Details - K091937

510(k) Number K091937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2009
Decision Date September 09, 2009
Days to Decision 71 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 160d · 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 12
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