Cleared Traditional

K781817 - OVU-GUIDE

K781817 is an FDA 510(k) clearance for OVU-GUIDE, manufactured by Reproduction Research Laboratories. The device is a Class 2 General Hospital device with product code FLK cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K781817 · Reproduction Research Laboratories · General Hospital
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Dec 1978
Decision
35d
Days
Class 2
Risk

K781817 is an FDA 510(k) clearance for the OVU-GUIDE. Classified as Thermometer, Clinical Mercury (product code FLK), Class II - Special Controls.

Submitted by Reproduction Research Laboratories (Mchenry, US). The FDA issued a Cleared decision on December 4, 1978 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2920 - the FDA general hospital 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 Reproduction Research Laboratories devices

FDA 510(k) Submission Details - K781817

510(k) Number K781817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1978
Decision Date December 04, 1978
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLK Device Classification - Class 2, Special Controls

Product Code FLK Thermometer, Clinical Mercury
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2920
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 General Hospital devices follow this clearance model.

Regulatory Peers - FLK Thermometer, Clinical Mercury

All 13
Devices cleared under the same product code (FLK) and FDA review panel - the closest regulatory comparables to K781817.
THERMOMETERS
K813424 · Abco Dealers, Inc. · Dec 1981
DISPOSABLE TEMPERATURE PROBE
K792426 · Hospitak, Inc. · Jan 1980
TEMPO2-II DISPOSABLE THERMOMETERS
K790891 · Airlife, Inc. · Jun 1979
THERMOMETER KIT
K780591 · Abco Dealers, Inc. · Apr 1978
THERMOMETER SHEATHS
K772365 · Medline Industries, Inc. · Jan 1978
DISPOS-A-CARE THERMOMETER SHEATH
K770125 · Chesebrough-Pond'S U.S.A. Co. · Mar 1977