Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5530](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5530) → CAL — Laryngoscope, Non-Rigid

# CAL · Laryngoscope, Non-Rigid

_Anesthesiology · 21 CFR 868.5530 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAL

## Overview

- **Product Code:** CAL
- **Device Name:** Laryngoscope, Non-Rigid
- **Regulation:** [21 CFR 868.5530](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5530)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K951195](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAL/K951195.md) | FI-10P | Pentax Precision Instrument Corp. | Apr 6, 1995 | SESE |
| [K951194](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAL/K951194.md) | FI-10M | Pentax Precision Instrument Corp. | Apr 6, 1995 | SESE |
| [K872895](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAL/K872895.md) | HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. | Haemonetics Corp. | Jan 11, 1988 | SESE |
| [K852994](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAL/K852994.md) | REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11 | Reichert-Jung, Inc. | Jul 29, 1985 | SESE |
| [K850978](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAL/K850978.md) | OLYMPUS LF-1 INTUBATION SCOPE | Olympus Corp. | May 23, 1985 | SESE |
| [K802331](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAL/K802331.md) | AO FLEXIBLE LARYNGOSCOPE, #LS-7 | American Optical Corp. | Oct 10, 1980 | SESE |
| [K801364](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAL/K801364.md) | AO STYLET LARYNGOSCOPE MODEL SLS | American Optical Corp. | Jun 17, 1980 | SESE |
| [K791634](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAL/K791634.md) | AO STYLET LARYNGOSCOPE, MODEL SLS-1 | American Optical Corp. | Sep 17, 1979 | SESE |

## Top Applicants

- American Optical Corp. — 3 clearances
- Pentax Precision Instrument Corp. — 2 clearances
- Haemonetics Corp. — 1 clearance
- Olympus Corp. — 1 clearance
- Reichert-Jung, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAL](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAL)

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