Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart B — Obstetrical and Gynecological Diagnostic Devices](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices) → [21 CFR 884.1560](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1560) → HGW — Sampler, Blood, Fetal

# HGW · Sampler, Blood, Fetal

_Obstetrics/Gynecology · 21 CFR 884.1560 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW

## Overview

- **Product Code:** HGW
- **Device Name:** Sampler, Blood, Fetal
- **Regulation:** [21 CFR 884.1560](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1560)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **3rd-party reviewable:** yes

## Identification

A fetal blood sampler is a device used to obtain fetal blood transcervically through an endoscope by puncturing the fetal skin with a short blade and drawing blood into a heparinized tube. The fetal blood pH is determined and used in the diagnosis of fetal distress and fetal hypoxia.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K891388](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW/K891388.md) | 1570 - FETAL BLOOD SAMPLING KIT | Transidyne General Corp. | Mar 28, 1989 | SESE |
| [K884685](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW/K884685.md) | ROCKET FETAL BLOOD SAMPLING TRAY | A & A Medical, Inc. | Jan 12, 1989 | SESE |
| [K831459](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW/K831459.md) | FETAL BLOOD SAMPLING KIT #1560 | Transidyne General Corp. | Jun 30, 1983 | SESE |
| [K810028](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW/K810028.md) | FETAL BLOOD SAMPLING KIT MODEL 1560 | Transidyne General Corp. | Jan 16, 1981 | SESE |

## Top Applicants

- Transidyne General Corp. — 3 clearances
- A & A Medical, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HGW)

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