Cleared Traditional

K042773 - ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS

K042773 is an FDA 510(k) clearance for ROSTAM SCENTED AND UNSCENTED PLASTIC AP..., manufactured by Rostam , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIL cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K042773 · Rostam , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
49d
Days
Class 2
Risk

K042773 is an FDA 510(k) clearance for the ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS. Classified as Tampon, Menstrual, Scented, Scented-deodorized (product code HIL), Class II - Special Controls.

Submitted by Rostam , Ltd. (Allendale, US). The FDA issued a Cleared decision on November 23, 2004 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5460 - 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.

FDA 510(k) Submission Details - K042773

510(k) Number K042773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2004
Decision Date November 23, 2004
Days to Decision 49 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 161d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIL Device Classification - Class 2, Special Controls

Product Code HIL Tampon, Menstrual, Scented, Scented-deodorized
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5460
Definition A Scented Or Scented-deodorized Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge.
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 - HIL Tampon, Menstrual, Scented, Scented-deodorized

All 77
Devices cleared under the same product code (HIL) and FDA review panel - the closest regulatory comparables to K042773.
PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
K060981 · Playtex Products, Inc. · May 2006
FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS
K051446 · First Quality Hygienic, Inc. · Jul 2005
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
K050067 · First Quality Hygienic, Inc. · Feb 2005
TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS
K040312 · Procter & Gamble Co. · May 2004
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
K032173 · First Quality Hygienic, Inc. · Sep 2003
ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS
K032080 · Rostam , Ltd. · Aug 2003
K042773 · ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
Download PDF FDA Summary Rostam , Ltd.