Cleared Traditional

K843886 - SCENTED BREATHABLE PRIVATE LABEL MINI-SH

K843886 is the FDA 510(k) clearance for SCENTED BREATHABLE PRIVATE LABEL MINI-SH by I.C.D. Industries, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HHL) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K843886 · I.C.D. Industries, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
23d
Days
Class 2
Risk

K843886 is an FDA 510(k) clearance for the SCENTED BREATHABLE PRIVATE LABEL MINI-SH. Classified as Pad, Menstrual, Scented, Scented-deodorized (product code HHL), Class II - Special Controls.

Submitted by I.C.D. Industries, Inc. (King Of Prussia, US). The FDA issued a Cleared decision on October 25, 1984 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5425 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all I.C.D. Industries, Inc. devices

Submission Details

510(k) Number K843886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1984
Decision Date October 25, 1984
Days to Decision 23 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d faster than avg
Panel avg: 160d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HHL Pad, Menstrual, Scented, Scented-deodorized
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5425
Definition Scented Or Scented-deodorized Menstrual Pads Used To Absorb Menstrual Or Other Vaginal Discharge, Including Those Intended As Intralabial Pads Or Reusable Menstrual Pads. These Are Made With Materials That Do Not Meet The Requirements For Class 1 Per 21 Cfr 884.5425(b).
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 - HHL Pad, Menstrual, Scented, Scented-deodorized

All 38
Devices cleared under the same product code (HHL) and FDA review panel - the closest regulatory comparables to K843886.
DEODORANT SUPER MAXITHINS BODY-SHAPED MAXI PADS
K843958 · Tambrands, Inc. · Nov 1984
DEODORANT REGULAR MAXITHINS BODY-SHAPED MAXI PADS
K843959 · Tambrands, Inc. · Nov 1984
DEODORANT MAXITHINS BODY-SHAPED PANTY SHIELDS
K843960 · Tambrands, Inc. · Nov 1984
SURE & NATURAL DEODORANT MAXI-SHIELD
K843155 · Johnson & Johnson Professionals, Inc. · Aug 1984
ASSURE-BREATHABLE PANTY LINERS/SCENT
K841312 · Personal Products Co. · Aug 1984
SCENTED MENSTRUAL PAD
K842764 · Procter & Gamble Mfg. Co. · Aug 1984