LBIClass II
Unit, Neonatal Phototherapy
21 CFR 880.5700 / General Hospital
LBI is the FDA product code for Unit, Neonatal Phototherapy, a class II device type, regulated under 21 CFR 880.5700. As of , FDA records hold 71 510(k) clearances under this code, the most recent dated , and 14 recalls.
Classification record
- Product code
- LBI
- Device name
- Unit, Neonatal Phototherapy
- Regulation
- 21 CFR 880.5700
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 71
- Ingested recalls
- 14
Clearances, product code LBI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 1 |
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 2 |
| 1983 | 2 |
| 1984 | 3 |
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 3 |
| 1990 | 3 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 3 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 5 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code LBI| Applicant | Clearances |
|---|---|
| Olympic Medical Corp. | 6 |
| Physician Engineered Products, Inc. | 6 |
| Natus Medical Incorporated | 4 |
| Air-Shields, Inc. | 3 |
| Medix I.C.S.A. | 3 |
| GE Healthcare | 3 |
| Atom Medical Corporation | 2 |
| Draeger Medical Systems, Inc. | 2 |
| E & B Technologies, Inc. | 2 |
| Lumitex Medical Devices, Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.