FDA product code LBI: Unit, Neonatal Phototherapy
LBI is the FDA product code for unit, neonatal phototherapy. It is a Class II device, regulated under 21 CFR 880.5700 and reviewed by the General Hospital panel. FDA has cleared 71 510(k) submissions under LBI, 2 in the last five years, from 45 different applicants. The average 510(k) review took 134 days (median 116); 236 days on average over the last three years. FDA has posted 14 recalls for LBI devices.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Neonatal Phototherapy |
| Device class | Class II |
| Regulation | 21 CFR 880.5700 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LBI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 268 |
| 2018 | 2 | 180 |
| 2019 | 1 | 150 |
| 2020 | 1 | 272 |
| 2021 | 1 | 115 |
| 2025 | 1 | 211 |
| 2026 | 1 | 262 |
Compare with all 510(k) review times · Search every LBI clearance
Top LBI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Physician Engineered Products, Inc. | 6 | 2012-02-03 |
| Olympic Medical Corp. | 6 | 1997-09-24 |
| Natus Medical Incorporated | 4 | 2018-12-13 |
| Medix I.C.S.A. | 3 | 2011-08-15 |
| Ohmeda Medical | 3 | 2001-07-19 |
40 more applicants have LBI clearances. See the full list in Caduvo.
Most recent LBI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251308 | Thera B Medical Products | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) | 2026-01-15 | 262 |
| K243372 | Gerium Medical, Ltd. | BiliWrap | 2025-05-29 | 211 |
| K210289 | Bistos Co., Ltd. | Infant Phototherapy Equipment | 2021-05-28 | 115 |
| K200031 | Avalon Biomedical (Shenzhen) Limited | Neonatal Phototherapy System | 2020-10-05 | 272 |
| K190899 | Little Sparrows Technologies, Inc. | bili-hut | 2019-09-05 | 150 |
Recalls for LBI devices
14 product recalls in 14 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-12-11.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code LBI?
LBI is the FDA product code for unit, neonatal phototherapy. It is a Class II device, regulated under 21 CFR 880.5700 and reviewed by the General Hospital panel.
What device class is LBI?
Class II, regulation 21 CFR 880.5700. Typical premarket route: 510(k).
How long does a 510(k) take for product code LBI?
Across 71 cleared submissions the average was 134 days from receipt to decision (median 116).
Which companies have the most LBI clearances?
Physician Engineered Products, Inc. (6); Olympic Medical Corp. (6); Natus Medical Incorporated (4); Medix I.C.S.A. (3); Ohmeda Medical (3).
Have LBI devices been recalled?
Yes: 14 product recalls across 14 recall events; the most recent began 2019-12-11.
Next steps
- Run an FDA pathway report with predicate devices for product code LBI
- Run a recall and safety report across every LBI manufacturer
- Watch product code LBI 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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