Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart G — Manual Hematology Devices](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices) → [21 CFR 864.6100](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6100) → JCA — Device, Bleeding Time

# JCA · Device, Bleeding Time

_Hematology · 21 CFR 864.6100 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA

## Overview

- **Product Code:** JCA
- **Device Name:** Device, Bleeding Time
- **Regulation:** [21 CFR 864.6100](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6100)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A bleeding time device is a device, usually employing two spring-loaded blades, that produces two small incisions in the patient's skin. The length of time required for the bleeding to stop is a measure of the effectiveness of the coagulation system, primarily the platelets.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K911745](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA/K911745.md) | SIMPLATE PEDIATRIC | Organon Teknika Corp. | Aug 9, 1991 | SESE |
| [K911996](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA/K911996.md) | SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION | International Technidyne Corp. | Jul 17, 1991 | SESE |
| [K871318](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA/K871318.md) | Q.I.C. BLEEDING TIME DEVICE | Helena Laboratories | Jun 10, 1987 | SESE |
| [K850542](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA/K850542.md) | SURGICUTT - BLEEDING TIME DEVICE | International Technidyne Corp. | Mar 1, 1985 | SESE |
| [K830645](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA/K830645.md) | BLEEDING TIME DEVICE DISPOSABLE | American Dade | Mar 17, 1983 | SESE |
| [K801815](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA/K801815.md) | AUTOLET | Ulster Scientific, Inc. | Oct 10, 1980 | SESE |
| [K761250](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA/K761250.md) | SIMPLATE | General Diagnostics | Mar 1, 1977 | SESE |

## Top Applicants

- International Technidyne Corp. — 2 clearances
- American Dade — 1 clearance
- General Diagnostics — 1 clearance
- Helena Laboratories — 1 clearance
- Organon Teknika Corp. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JCA)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com