FDA product code LYN: Apparatus, Visual Reinforcement Audiometric
LYN is the FDA product code for apparatus, visual reinforcement audiometric. It is a Class II device, regulated under 21 CFR 874.1050 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 3 510(k) submissions under LYN, from 3 different applicants. The average 510(k) review took 225 days (median 121).
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Visual Reinforcement Audiometric |
| Device class | Class II |
| Regulation | 21 CFR 874.1050 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LYN clearance
Top LYN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1995-06-28 |
| Madsen North America, Inc. | 1 | 1990-04-27 |
| Colorado Hearing Systems, Inc. | 1 | 1989-04-03 |
Most recent LYN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950995 | Bd Becton Dickinson Vacutainer Systems Preanalytic | SENSICARE SYNTHETIC, SURGICAL GLOVE LINER | 1995-06-28 | 117 |
| K897143 | Madsen North America, Inc. | VERA 103 | 1990-04-27 | 121 |
| K880259 | Colorado Hearing Systems, Inc. | VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV | 1989-04-03 | 437 |
Recalls for LYN devices
openFDA lists no recalls for product code LYN.
Frequently asked questions
What is FDA product code LYN?
LYN is the FDA product code for apparatus, visual reinforcement audiometric. It is a Class II device, regulated under 21 CFR 874.1050 and reviewed by the Ear, Nose and Throat panel.
What device class is LYN?
Class II, regulation 21 CFR 874.1050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LYN?
Across 3 cleared submissions the average was 225 days from receipt to decision (median 121).
Which companies have the most LYN clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Madsen North America, Inc. (1); Colorado Hearing Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LYN
- Run a recall and safety report across every LYN manufacturer
- Watch product code LYN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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