Cleared Traditional

K915844 - EXACT-TOUCH

K915844 is an FDA 510(k) clearance for EXACT-TOUCH, manufactured by Baal Assoc., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 743-day FDA review.

K915844 · Baal Assoc., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
743d
Days
Class 2
Risk

K915844 is an FDA 510(k) clearance for the EXACT-TOUCH. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Baal Assoc., Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 7, 1994 after a review of 743 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Baal Assoc., Inc. devices

FDA 510(k) Submission Details - K915844

510(k) Number K915844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1991
Decision Date January 07, 1994
Days to Decision 743 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
583d slower than avg
Panel avg: 160d · This submission: 743d
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 34
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K915844.
PURITAN FOAM TIP SWAB MODEL 2197
K961934 · Hardwood Products Co., LP · Jul 1996
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