Cleared Traditional

K021012 - LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM

K021012 is an FDA 510(k) clearance for LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM, manufactured by Quality Medical Solusions, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HDY cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K021012 · Quality Medical Solusions, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
88d
Days
Class 2
Risk

K021012 is an FDA 510(k) clearance for the LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM. Classified as Dilator, Cervical, Hygroscopic-laminaria (product code HDY), Class II - Special Controls.

Submitted by Quality Medical Solusions, LLC (Alpharetta, US). The FDA issued a Cleared decision on June 25, 2002 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4260 - 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 - K021012

510(k) Number K021012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2002
Decision Date June 25, 2002
Days to Decision 88 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
73d faster than avg
Panel avg: 161d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HDY Device Classification - Class 2, Special Controls

Product Code HDY Dilator, Cervical, Hygroscopic-laminaria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4260
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 - HDY Dilator, Cervical, Hygroscopic-laminaria

All 9
Devices cleared under the same product code (HDY) and FDA review panel - the closest regulatory comparables to K021012.
ATAD ARD CATHETER
K040625 · Atad Developments , Ltd. · Jan 2005
MMODIFICATION TO LAMINARIA
K011512 · A & A Medical, Inc. · Jul 2001
LAMINARIA
K955072 · Cti Corp., Ltd. · May 1996
LAMINARIA TENT
K892220 · Berkeley Medevices · Jun 1989
LAMINARIA CUREX
K881295 · Harold W. Berger Co. · Aug 1988
LAMINARIA
K881312 · Busse Hospital Disposables, Inc. · May 1988
K021012 · LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
Download PDF FDA Summary Quality Medical Solus…