Cleared Traditional

K925501 - NYLON COATED SPECULA

K925501 is the FDA 510(k) clearance for NYLON COATED SPECULA by Zinnanti Surgical Instruments, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIB) cleared through the Traditional 510(k) pathway after a 1687-day FDA review.

K925501 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology device
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Jun 1997
Decision
1687d
Days
Class 2
Risk

K925501 is an FDA 510(k) clearance for the NYLON COATED SPECULA. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on June 13, 1997 after a review of 1687 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Zinnanti Surgical Instruments, Inc. devices

Submission Details

510(k) Number K925501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1992
Decision Date June 13, 1997
Days to Decision 1687 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1527d slower than avg
Panel avg: 160d · This submission: 1687d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 10
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K925501.
SPECULUM, VAGINAL, NONMETAL
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K070964 · Welch Allyn, Inc. · May 2007
VERSA-VU
K951898 · CooperSurgical, Inc. · Dec 1995
KLEENSPEC
K941272 · Welch Allyn, Inc. · Aug 1994
THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV
K930954 · Cabot Medical Corp. · Jun 1994