Cleared Traditional

K111681 - HISTOBRUSH

K111681 is an FDA 510(k) clearance for HISTOBRUSH, manufactured by Puritan Medical Products Company, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K111681 · Puritan Medical Products Company, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
218d
Days
Class 2
Risk

K111681 is an FDA 510(k) clearance for the HISTOBRUSH. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Puritan Medical Products Company, LLC (Guilford, US). The FDA issued a Cleared decision on January 19, 2012 after a review of 218 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 Puritan Medical Products Company, LLC devices

FDA 510(k) Submission Details - K111681

510(k) Number K111681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2011
Decision Date January 19, 2012
Days to Decision 218 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
58d slower than avg
Panel avg: 160d · This submission: 218d
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 15
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K111681.
exCellerator Cervical Collection Device
K182049 · Excell Company, LLC · Apr 2019
DETECT CYTOLOGY BRUSH II
K960469 · Cook Urological, Inc. · Mar 1996
DETECT (TM) CYTOLOGY BRUSH
K933415 · Cook Ob/Gyn · Feb 1994
SPATULA FOR PAP SMEAR COLLECTION
K893229 · Medical Device Inspection Co., Inc. · Feb 1990
WALLACH CC/BRUSH
K896065 · Wallach Surgical Devices, Inc. · Jan 1990
KOTEX SUPER MAXI PADS
K890013 · Kimberly-Clark Corp. · Apr 1989