Browse hierarchy: [Pathology (PA)](/submissions/PA) → [Subpart D — Pathology Instrumentation and Accessories](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories) → [21 CFR 864.3875](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/864.3875) → IEO — Processor, Tissue, Automated

# IEO · Processor, Tissue, Automated

_Pathology · 21 CFR 864.3875 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO

## Overview

- **Product Code:** IEO
- **Device Name:** Processor, Tissue, Automated
- **Regulation:** [21 CFR 864.3875](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/864.3875)
- **Device Class:** 1
- **Review Panel:** [Pathology](/submissions/PA)

## Identification

An automated tissue processor is an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.

## Classification Rationale

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K924590](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO/K924590.md) | MICROWAVE AUTOMATED TISSUE PROCESSOR | Innovative Medical Systems, Inc. | Dec 29, 1992 | SESE |
| [K883599](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO/K883599.md) | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | Innovative Medical Systems, Inc. | Sep 2, 1988 | SESE |
| [K881165](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO/K881165.md) | SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR | Sakura Finetek U.S.A., Inc. | Jul 1, 1988 | SESE |
| [K853938](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO/K853938.md) | LX 300 TISSUE PROCESSOR | Innovative Medical Systems, Inc. | Oct 10, 1985 | SESE |
| [K851054](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO/K851054.md) | LX120 TISSUE PROCESSOR | Innovative Medical Systems, Inc. | May 15, 1985 | SESE |
| [K843506](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO/K843506.md) | LKB 2189 ULTROPROCESSOR | Lkb Instruments, Inc. | Nov 30, 1984 | SESE |
| [K834599](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO/K834599.md) | AUTOTECHNICON V TISSUE PROCESS SYS | Technicon Instruments Corp. | Feb 4, 1984 | SESE |
| [K831313](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO/K831313.md) | TISSUE-TEK V.I.P. 100/200 | Miles Laboratories, Inc. | Jul 28, 1983 | SESE |
| [K801513](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO/K801513.md) | TISSUE PROCESSING SYSTEM | Innovative Medical Systems, Inc. | Jul 28, 1980 | SESE |
| [K801427](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO/K801427.md) | TISSUE-TEK III MINI-RAPID PROCESSOR | Miles Laboratories, Inc. | Jul 28, 1980 | SESE |
| [K771308](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO/K771308.md) | TISSUE-TEK III V.I.P. | Miles Laboratories, Inc. | Aug 22, 1977 | SESE |
| [K761062](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO/K761062.md) | HISTO-TEK W/ AUTOMATIC COVERSLIPPER | Miles Laboratories, Inc. | Mar 7, 1977 | SESE |

## Top Applicants

- Innovative Medical Systems, Inc. — 5 clearances
- Miles Laboratories, Inc. — 4 clearances
- Lkb Instruments, Inc. — 1 clearance
- Sakura Finetek U.S.A., Inc. — 1 clearance
- Technicon Instruments Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IEO)

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