Cleared Traditional

K013258 - INPATH E2 COLLECTOR

K013258 is an FDA 510(k) clearance for INPATH E2 COLLECTOR, manufactured by Molecular Diagnostics. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K013258 · Molecular Diagnostics · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
242d
Days
Class 2
Risk

K013258 is an FDA 510(k) clearance for the INPATH E2 COLLECTOR. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Molecular Diagnostics (Chicago, US). The FDA issued a Cleared decision on May 31, 2002 after a review of 242 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.

View all Molecular Diagnostics devices

FDA 510(k) Submission Details - K013258

510(k) Number K013258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2001
Decision Date May 31, 2002
Days to Decision 242 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 160d · This submission: 242d
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 29
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K013258.
Kolplast Cervical Sample Collection Kit
K153128 · Kolplast CI SA · Jan 2017
DISPOSABLE CERVICAL BRUSH
K141057 · Ningbo Hls Medical Products Co., Ltd. · May 2015
HISTOBRUSH
K111681 · Puritan Medical Products Company, LLC · Jan 2012
ORIBRUSH - STANDARD - B002
K991593 · Orifice Medical AB · Jun 1999
ORIBRUSH - WITH PROTECTIVE TIP - B001
K991595 · Orifice Medical AB · Jun 1999
HARWILL MEDICAL CERVITULA CERVICAL SPATULA
K983202 · Harwill Medical (Pty) , Ltd. · Mar 1999