FDA product code LLN: Device, Vibration Threshold Measurement
LLN is the FDA product code for device, vibration threshold measurement. It is a Class I device, regulated under 21 CFR 882.1200 and reviewed by the Neurology panel. FDA has cleared 13 510(k) submissions under LLN, from 13 different applicants. The average 510(k) review took 240 days (median 266).
Classification
| Field | Value |
|---|---|
| Device name | Device, Vibration Threshold Measurement |
| Device class | Class I |
| Regulation | 21 CFR 882.1200 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Top LLN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Osachi Co., Ltd. | 1 | 2009-01-08 |
| Xilas Medical, Inc. | 1 | 2003-12-05 |
| Medoc Ltd. Advanced Medical Systems | 1 | 2001-09-20 |
| Neuro-Diagnostic Assoc. | 1 | 1997-12-01 |
| Pentax Precision Instrument Corp. | 1 | 1997-09-04 |
8 more applicants have LLN clearances. See the full list in Caduvo.
Most recent LLN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072882 | Osachi Co., Ltd. | PAIN VISION, MODEL PS-2100 | 2009-01-08 | 457 |
| K030829 | Xilas Medical, Inc. | VPT METER | 2003-12-05 | 266 |
| K010981 | Medoc Ltd. Advanced Medical Systems | GSA GENITO SENSORY ANALYZER | 2001-09-20 | 171 |
| K964622 | Neuro-Diagnostic Assoc. | MEDI-DX 7000 | 1997-12-01 | 378 |
| K964815 | Pentax Precision Instrument Corp. | AP-4000, AIR PULSE SENSORY STIMULATOR | 1997-09-04 | 279 |
Recalls for LLN devices
openFDA lists no recalls for product code LLN.
Frequently asked questions
What is FDA product code LLN?
LLN is the FDA product code for device, vibration threshold measurement. It is a Class I device, regulated under 21 CFR 882.1200 and reviewed by the Neurology panel.
What device class is LLN?
Class I, regulation 21 CFR 882.1200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LLN?
Across 13 cleared submissions the average was 240 days from receipt to decision (median 266).
Which companies have the most LLN clearances?
Osachi Co., Ltd. (1); Xilas Medical, Inc. (1); Medoc Ltd. Advanced Medical Systems (1); Neuro-Diagnostic Assoc. (1); Pentax Precision Instrument Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LLN
- Run a recall and safety report across every LLN manufacturer
- Watch product code LLN 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.