Cleared Traditional

K001615 - HUNTER SCIENTIFIC INJECTION PIPETTES

K001615 is an FDA 510(k) clearance for HUNTER SCIENTIFIC INJECTION PIPETTES, manufactured by Hunter Scientific Limited. The device is a Class 2 Obstetrics & Gynecology device with product code MQH cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K001615 · Hunter Scientific Limited · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
85d
Days
Class 2
Risk

K001615 is an FDA 510(k) clearance for the HUNTER SCIENTIFIC INJECTION PIPETTES. Classified as Microtools, Assisted Reproduction (pipettes) (product code MQH), Class II - Special Controls.

Submitted by Hunter Scientific Limited (Saffron Walden, Essex, GB). The FDA issued a Cleared decision on August 18, 2000 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6130 - 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 - K001615

510(k) Number K001615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2000
Decision Date August 18, 2000
Days to Decision 85 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
76d faster than avg
Panel avg: 161d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQH Device Classification - Class 2, Special Controls

Product Code MQH Microtools, Assisted Reproduction (pipettes)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6130
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 - MQH Microtools, Assisted Reproduction (pipettes)

All 26
Devices cleared under the same product code (MQH) and FDA review panel - the closest regulatory comparables to K001615.
PRECISION CAPILLARIES FOR MICROMANIPULATION
K024302 · Brinkmann Instruments, Inc. · Feb 2003
BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540
K022643 · Swemed Lab International AB · Nov 2002
BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B
K012811 · Humagen Fertility Diagnostics, Inc. · Feb 2002
THE STRIPPER
K993699 · Mid-Atlantic Diagnostics, Inc. · May 2000
ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M
K991388 · Pacific Andrology, Inc. · Sep 1999
ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET
K991261 · Research Instruments , Ltd. · Aug 1999
K001615 · HUNTER SCIENTIFIC INJECTION PIPETTES
Download PDF FDA Summary Hunter Scientific Lim…