TRACER
510(k) K881842
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK881842 | Date31 Aug 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2775
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The TRACER is a battery-powered nerve stimulator classified under the medical specialty of anesthesiology. It is a device designed for electrical stimulation of nerves in clinical settings.
The device received FDA 510(k) clearance (K881842) on August 31, 1988, and is classified as a Class II medical device under regulation 868.2775. It is supplied as a reusable device and is intended for use in anesthesiology-related procedures.
Other devices from Life-Tech Intl., Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the TRACER device used for?
The TRACER is designed for electrical stimulation of nerves in clinical settings, specifically within the medical specialty of anesthesiology, to assist in nerve localization or assessment during procedures.
Is the TRACER device reusable or single-use?
The TRACER is supplied as a reusable device, meaning it can be cleaned and used multiple times following appropriate reprocessing protocols, as indicated in its FDA 510(k) clearance documentation.
When did the TRACER receive FDA clearance and under what pathway?
The TRACER received FDA 510(k) clearance on August 31, 1988, under the traditional pathway, with clearance number K881842, demonstrating substantial equivalence to a legally marketed predicate device.