FDA product code LIO: Device, Specimen Collection
LIO is the FDA product code for device, specimen collection. It is a Class I device, regulated under 21 CFR 866.2900 and reviewed by the Microbiology panel. FDA has cleared 63 510(k) submissions under LIO, 1 in the last five years, from 44 different applicants. The average 510(k) review took 86 days (median 77); 575 days on average over the last three years. FDA has posted 3 recalls for LIO devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Specimen Collection |
| Device class | Class I |
| Regulation | 21 CFR 866.2900 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LIO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 575 |
Compare with all 510(k) review times · Search every LIO clearance
Top LIO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Remel Co. | 4 | 2001-11-26 |
| Pro-Lab Diagnostics | 4 | 1992-12-24 |
| Sage Products, Inc. | 3 | 1996-11-08 |
| Medical Laboratory Automation Systems, Inc. | 3 | 1991-01-18 |
| Puritan Medical Products, LLC | 2 | 2013-10-21 |
39 more applicants have LIO clearances. See the full list in Caduvo.
Most recent LIO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222613 | Arx Sciences, Inc. | ARX Liquid Amies Collection & Transport System | 2024-03-27 | 575 |
| K131630 | Puritan Medical Products, LLC | PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM | 2013-10-21 | 139 |
| K120846 | Puritan Medical Products, LLC | TRANSPORT CULTURE MEDIUM DEVICE | 2012-06-08 | 80 |
| K103805 | Medical Wire & Equipment Company (Bath), Ltd. | MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE | 2011-01-25 | 28 |
| K082472 | Medical Wire & Equipment Company (Bath), Ltd. | VIROCULT, MODEL MW950 | 2008-12-30 | 124 |
Recalls for LIO devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2025-01-08.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code LIO?
LIO is the FDA product code for device, specimen collection. It is a Class I device, regulated under 21 CFR 866.2900 and reviewed by the Microbiology panel.
What device class is LIO?
Class I, regulation 21 CFR 866.2900. Typical premarket route: 510(k).
How long does a 510(k) take for product code LIO?
Across 63 cleared submissions the average was 86 days from receipt to decision (median 77).
Which companies have the most LIO clearances?
Remel Co. (4); Pro-Lab Diagnostics (4); Sage Products, Inc. (3); Medical Laboratory Automation Systems, Inc. (3); Puritan Medical Products, LLC (2).
Have LIO devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2025-01-08.
Next steps
- Run an FDA pathway report with predicate devices for product code LIO
- Run a recall and safety report across every LIO manufacturer
- Watch product code LIO 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times