Caesarea Medical Electronics , Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Caesarea Medical Electronics , Ltd.” (first 2003, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 78 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRN | Pump, Infusion | 8 | 8 |
| LZH | Pump, Infusion, Enteral | 1 | 1 |
Review panels
- General Hospital (9)
Most recent Caesarea Medical Electronics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080954 | T34L SYRINGE DRIVER | FRN | 2008-05-16 | 43 |
| K070235 | BODYGUARD PAIN MANAGER INFUSION SYSTEM | FRN | 2007-05-18 | 113 |
| K070718 | MODIFICATION TO: BODYGUARD INFUSION SYSTEM | FRN | 2007-04-13 | 30 |
| K061325 | BODYGAURD PAIN MANAGER INFUSION SYSTEM | FRN | 2006-08-24 | 105 |
| K060479 | MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM | FRN | 2006-05-12 | 78 |
| K050800 | NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS | FRN | 2005-11-23 | 238 |
| K042696 | BODYGUARD INFUSION PUMP SYSTEM | FRN | 2005-03-11 | 162 |
| K040957 | NOA III ENTERAL NUTRITION PUMP | LZH | 2004-05-21 | 38 |
| K031749 | BODYGUARD INFUSION SYSTEM | FRN | 2003-08-21 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Caesarea Medical Electronics , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Caesarea Medical Electronics , Ltd. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under Caesarea Medical Electronics , Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Caesarea Medical Electronics , Ltd.” (first 2003, latest 2008), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Caesarea Medical Electronics , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Caesarea Medical Electronics , Ltd. is 78 days.
Which FDA product codes appear under Caesarea Medical Electronics , Ltd.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 8); LZH (Pump, Infusion, Enteral, 1).
Next steps
- See all 9 Caesarea Medical Electronics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Caesarea Medical Electronics , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.