Cleared Traditional

K041579 - MEDELA SINGLE USE SILC CUP, MODEL 077.0791

K041579 is an FDA 510(k) clearance for MEDELA SINGLE USE SILC CUP, manufactured by Medela AG. The device is a Class 2 Obstetrics & Gynecology device with product code HDB cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K041579 · Medela AG · Obstetrics & Gynecology device
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Apr 2005
Decision
311d
Days
Class 2
Risk

K041579 is an FDA 510(k) clearance for the MEDELA SINGLE USE SILC CUP, MODEL 077.0791. Classified as Extractor, Vacuum, Fetal (product code HDB), Class II - Special Controls.

Submitted by Medela AG (Baar Zug, CH). The FDA issued a Cleared decision on April 21, 2005 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4340 - 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. Elevated predicate reliance profile. 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 Medela AG devices

FDA 510(k) Submission Details - K041579

510(k) Number K041579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2004
Decision Date April 21, 2005
Days to Decision 311 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 160d · This submission: 311d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

HDB Device Classification - Class 2, Special Controls

Product Code HDB Extractor, Vacuum, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4340
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 Consultant

Tuv America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HDB Extractor, Vacuum, Fetal

All 14
Devices cleared under the same product code (HDB) and FDA review panel - the closest regulatory comparables to K041579.
Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M)
K250298 · Clinical Innovations, LLC · Oct 2025
VACULINK, MODEL VCL 3000
K043614 · Medevco, Inc. · Apr 2005
KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
K981260 · Clinical Innovations, Inc. · Sep 1998
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
K980976 · Hollister, Inc. · Aug 1998
MITYVAC
K980212 · Prism Technologies, Inc. · Jul 1998
SWIFT DELIVERY PRODUCT #300
K973942 · Swift Delivery Products · Dec 1997

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.