Cleared Traditional

K081522 - BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY

K081522 is an FDA 510(k) clearance for BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL ..., manufactured by Bio Nuclear Diagnostics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K081522 · Bio Nuclear Diagnostics, Inc. · Obstetrics & Gynecology device
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Dec 2008
Decision
189d
Days
Class 2
Risk

K081522 is an FDA 510(k) clearance for the BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Bio Nuclear Diagnostics, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on December 5, 2008 after a review of 189 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K081522

510(k) Number K081522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2008
Decision Date December 05, 2008
Days to Decision 189 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
28d slower than avg
Panel avg: 161d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHT Device Classification - Class 2, Special Controls

Product Code HHT Spatula, Cervical, Cytological
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 - HHT Spatula, Cervical, Cytological

All 67
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K081522.
DISPOSABLE CERVICAL BRUSH
K141057 · Ningbo Hls Medical Products Co., Ltd. · May 2015
HISTOBRUSH
K111681 · Puritan Medical Products Company, LLC · Jan 2012
PAPCONE
K083012 · Otto Bock Pur Life Science GmbH · Apr 2009
SOFTPAP CERVICAL CELL COLLECTOR
K072381 · Cytocore, Inc. · Jan 2008
DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
K062433 · Diamics, Inc. · Mar 2007
CERVEX-BRUSH COMBI
K043369 · Rovers Medical Devices B.V. · Feb 2005
K081522 · BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
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