Cleared Traditional

K930400 - TERRA FEMME

K930400 is an FDA 510(k) clearance for TERRA FEMME, manufactured by Bio Business Intl, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 412-day FDA review.

K930400 · Bio Business Intl, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
412d
Days
Class 2
Risk

K930400 is an FDA 510(k) clearance for the TERRA FEMME. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Bio Business Intl, Inc. (Canada M6g 3x3, CA). The FDA issued a Cleared decision on March 14, 1994 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5470 - 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 Bio Business Intl, Inc. devices

FDA 510(k) Submission Details - K930400

510(k) Number K930400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date March 14, 1994
Days to Decision 412 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
252d slower than avg
Panel avg: 160d · This submission: 412d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEB Device Classification - Class 2, Special Controls

Product Code HEB Tampon, Menstrual, Unscented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5470
Definition An Unscented 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 - HEB Tampon, Menstrual, Unscented

All 157
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K930400.
UNSCENTED MENSTRUAL TAMPONS
K944834 · Tambrands, Inc. · Dec 1994
PLAYTEX TAMPONS MODEL 13794
K942418 · Playtex, Inc. · Jul 1994
O.B. TAMPON
K941863 · Personal Products Co. · Jun 1994
KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+
K930149 · Kimberly-Clark Corp. · Mar 1994
TAMPAX TAMPONS, SUPER ABSORBENCY
K923932 · Tambrands, Inc. · Jul 1993
TAMPAX TAMPON, REGULAR ABSORBENCY
K924303 · Tambrands, Inc. · Jul 1993