Cleared Traditional

K810028 - FETAL BLOOD SAMPLING KIT MODEL 1560 (FDA 510(k) Clearance)

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

K810028 · Transidyne General Corp. · Obstetrics & Gynecology device
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Jan 1981
Decision
10d
Days
Class 2
Risk

K810028 is an FDA 510(k) clearance for the FETAL BLOOD SAMPLING KIT MODEL 1560. Classified as Sampler, Blood, Fetal (product code HGW), Class II - Special Controls.

Submitted by Transidyne General Corp. (Mchenry, US). The FDA issued a Cleared decision on January 16, 1981 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1560 - 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 Transidyne General Corp. devices

Submission Details

510(k) Number K810028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1981
Decision Date January 16, 1981
Days to Decision 10 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d faster than avg
Panel avg: 160d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGW Sampler, Blood, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1560
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.