Cleared Traditional

K891388 - 1570 - FETAL BLOOD SAMPLING KIT (FDA 510(k) Clearance)

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

K891388 · Transidyne General Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
14d
Days
Class 2
Risk

K891388 is an FDA 510(k) clearance for the 1570 - FETAL BLOOD SAMPLING KIT. Classified as Sampler, Blood, Fetal (product code HGW), Class II - Special Controls.

Submitted by Transidyne General Corp. (Ann Arbor, US). The FDA issued a Cleared decision on March 28, 1989 after a review of 14 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 K891388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1989
Decision Date March 28, 1989
Days to Decision 14 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
146d faster than avg
Panel avg: 160d · This submission: 14d
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.