Fetal Blood Sampling Kit Model 1560

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K810028 ↗

FDA Product Code

HGW

Device Class

Class II

Regulation

21 CFR Part 884.1560

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from Transidyne General Corp. →

• What clinical scenario is this fetal blood sampling kit primarily used for, and how does it work?

  This kit is designed for obtaining fetal blood samples transcervically to assess fetal distress or hypoxia. It uses a short blade to puncture the fetal skin through an endoscope, drawing blood into a heparinized tube for pH measurement. The procedure enables clinicians to diagnose potential complications during pregnancy by evaluating fetal blood acidity levels.

• Is this device intended for reuse, or is it meant to be used only once?

  The Fetal Blood Sampling Kit Model 1560 is explicitly supplied as a single-use assembly. It is not intended for reprocessing or reuse, as this could compromise sterility and device integrity, which are critical for safe obstetric procedures.

• How should this kit be stored to ensure it remains effective and sterile?

  Since the kit is single-use and intended for sterile obstetric use, it must be stored in a clean, dry environment protected from contamination. The manufacturer recommends adhering to standard sterile medical device storage protocols to preserve its integrity until use.

• What regulatory pathway was followed for this device’s clearance, and what does that mean for its use?

  The kit received FDA 510(k) clearance (K810028) under the Traditional pathway, determined to be *substantially equivalent* to a predicate device. This means it meets FDA standards for safety and effectiveness as a Class II device (regulation 884.1560) and is approved for use in obstetrics/gynecology settings as described.