Cleared Traditional

K891029 - CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL

K891029 is an FDA 510(k) clearance for CERVICAL DILATORS PRATT, manufactured by Zinnanti Surgical Instruments, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HDQ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K891029 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology device
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Mar 1989
Decision
17d
Days
Class 1
Risk

K891029 is an FDA 510(k) clearance for the CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL. Classified as Dilator, Cervical, Fixed Size (product code HDQ), Class I - General Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on March 17, 1989 after a review of 17 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 - K891029

510(k) Number K891029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1989
Decision Date March 17, 1989
Days to Decision 17 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d faster than avg
Panel avg: 161d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

HDQ Device Classification - Class 1, General Controls

Product Code HDQ Dilator, Cervical, Fixed Size
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HDQ Dilator, Cervical, Fixed Size

Devices cleared under the same product code (HDQ) and FDA review panel - the closest regulatory comparables to K891029.
CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON
K930034 · Thomasville Medical Assoc. · Feb 1994
TEFLON CERVICAL ACCESS SET
K896701 · Cook Ob/Gyn · Sep 1990
FIXED-SIZE UTERINE DILATOR
K890377 · Kinetic Medical Products · Feb 1989
CERVICAL DILATOR
K811568 · Gynemetrics, Inc. · Jul 1981
MODEL 6500 EXTRACTION IRRIGATION SYS
K791277 · Cavitron Corp. · Aug 1979
K891029 · CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL
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