Cleared Traditional

K083012 - PAPCONE

K083012 is an FDA 510(k) clearance for PAPCONE, manufactured by Otto Bock Pur Life Science GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K083012 · Otto Bock Pur Life Science GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
182d
Days
Class 2
Risk

K083012 is an FDA 510(k) clearance for the PAPCONE. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Otto Bock Pur Life Science GmbH (Duderstadt, Lower Saxony, DE). The FDA issued a Cleared decision on April 9, 2009 after a review of 182 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 - K083012

510(k) Number K083012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2008
Decision Date April 09, 2009
Days to Decision 182 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 161d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Sud America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K083012.
Kolplast Cervical Sample Collection Kit
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DISPOSABLE CERVICAL BRUSH
K141057 · Ningbo Hls Medical Products Co., Ltd. · May 2015
HISTOBRUSH
K111681 · Puritan Medical Products Company, LLC · Jan 2012
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
K081522 · Bio Nuclear Diagnostics, Inc. · Dec 2008
SOFTPAP CERVICAL CELL COLLECTOR
K072381 · Cytocore, Inc. · Jan 2008
DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
K062433 · Diamics, Inc. · Mar 2007

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K083012 · PAPCONE
Download PDF FDA Summary Otto Bock Pur Life Sc…