Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart B — Diagnostic Devices](/submissions/OR/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 888.1520](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/888.1520) → KQW — Goniometer, Nonpowered

# KQW · Goniometer, Nonpowered

_Orthopedic · 21 CFR 888.1520 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW

## Overview

- **Product Code:** KQW
- **Device Name:** Goniometer, Nonpowered
- **Regulation:** [21 CFR 888.1520](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/888.1520)
- **Device Class:** 1
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.

## 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 § 888.9.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K926237](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW/K926237.md) | O'BRIEN GONIOMETER | Sgarlato Laboratories, Inc. | Aug 2, 1993 | SESE |
| [K901744](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW/K901744.md) | DOBBHOFF(R) RETRIEVAL FORCEPS | Biosearch Medical Products, Inc. | Jul 3, 1990 | SESE |
| [K870767](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW/K870767.md) | THE (CROM) TESTER | Twin City Surgical, Inc. | Mar 17, 1987 | SESE |
| [K850082](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW/K850082.md) | HAND HELD GONIOMETER | Chattanooga Group, Inc. | Apr 4, 1985 | SESE |
| [K831550](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW/K831550.md) | FINGER BONIOMETER BK7506 | Fred Sammons, Inc. | Jun 24, 1983 | SESE |
| [K812778](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW/K812778.md) | THE TELOS EQUIPMENT | The Telos Co. | Dec 8, 1981 | SESE |
| [K810441](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW/K810441.md) | UNIVERSAL GONIMETER | Fred Sammons, Inc. | Feb 27, 1981 | SESE |
| [K801718](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW/K801718.md) | BK-7513 STAINLESS STEEL GONIOMETER | Fred Sammons, Inc. | Aug 4, 1980 | SESE |
| [K801717](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW/K801717.md) | BK-7511 BRASS GONIOMETER | Fred Sammons, Inc. | Aug 4, 1980 | SESE |
| [K801716](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW/K801716.md) | BK-7505 RADIOPAQUE GONIOMETER, 8 | Fred Sammons, Inc. | Aug 4, 1980 | SESE |
| [K801715](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW/K801715.md) | BK-7497 BULB DYNAMOMETER | Fred Sammons, Inc. | Aug 4, 1980 | SESE |
| [K760302](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW/K760302.md) | GONIOMETER, INTER. STAND. LARGE, BK7514 | Fred Sammons, Inc. | Sep 8, 1976 | SESE |
| [K760301](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW/K760301.md) | GONIOMETER, MED. INTER. STAND. BK-7512 | Fred Sammons, Inc. | Sep 8, 1976 | SESE |

## Top Applicants

- Fred Sammons, Inc. — 8 clearances
- Biosearch Medical Products, Inc. — 1 clearance
- Chattanooga Group, Inc. — 1 clearance
- Sgarlato Laboratories, Inc. — 1 clearance
- The Telos Co. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/KQW)

**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