Company ยท US
Bistos Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2025. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 2025 | K251512 | Hi bebe super (BT-150B) Bistos Co., Ltd., KR | HGX |
| Aug 28, 2024 | K232991 | BT-1000 Bistos Co., Ltd., KR | QGL |
| May 28, 2021 | K210289 | Infant Phototherapy Equipment Bistos Co., Ltd., KR | LBI |
| Feb 10, 2021 | K200675 | Hi bebe super (Models BT-150S and BT-150L) Bistos Co., Ltd., KR | HGX |
| Sep 1, 2016 | K160274 | Hi bebe plus Bistos Co., Ltd., KR | HGX |
| Jul 9, 2015 | K142799 | Model BT-220L and BT-220C Bistos Co., Ltd. | HGM |
| Jul 3, 2014 | K132543 | INFANT INCUBATOR Bistos Co., Ltd. | FMZ |
| Aug 2, 2012 | K121267 | BT-200V VASCULAR DOPPLER Bistos Co., Ltd. | HGM |
| May 13, 2011 | K103545 | BT-350 Bistos Co., Ltd. | HGM |
| Jun 7, 2010 | K100885 | FETAL MONITOR MODEL: BT-200T Bistos Co., Ltd. | HGM |
| Oct 4, 2005 | K052190 | FETAL MONITOR, MODELS BT-300 AND BT-200 Bistos Co., Ltd. | HGM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||