Cleared Traditional

HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU (K990913) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990913 · Laboratoires Prodimed · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
82d
Days
Class 2
Risk

K990913 is an FDA 510(k) clearance for the HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HO.... Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Laboratoires Prodimed (Ringoes, US). The FDA issued a Cleared decision on June 8, 1999 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6100 - 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 Laboratoires Prodimed devices

Submission Details

510(k) Number K990913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1999
Decision Date June 08, 1999
Days to Decision 82 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
78d faster than avg
Panel avg: 160d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQE Needle, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6100
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 - MQE Needle, Assisted Reproduction

All 31
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K990913.
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
K240523 · Shenzhen Vitavitro Biotech Co., Ltd. · Nov 2024
Lotus Single Lumen Ovum Aspiration Needle
K232163 · Zhejiang Horizon Medical Technology Co., Ltd. · Feb 2024
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
K190590 · Allwin Medical Devices, Inc. · Nov 2019
Wallace Dual Lumen Oocyte Recovery System
K191291 · CooperSurgical, Inc. · Jun 2019
Wallace Dual Lumen Oocyte Recovery System
K182959 · CooperSurgical, Inc. · May 2019
Single Lumen Ovum Aspiration Needles
K171625 · Willian A. Cook Australia Pty, Ltd. · Jan 2018