Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Caesarea Medical Electronics , Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
238 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080954 | T34L SYRINGE DRIVER | Caesarea Medical Electronics , Ltd. | 2008-05-16 | 43 | 0 |
| K070235 | BODYGUARD PAIN MANAGER INFUSION SYSTEM | Caesarea Medical Electronics , Ltd. | 2007-05-18 | 113 | 0 |
| K070718 | MODIFICATION TO: BODYGUARD INFUSION SYSTEM | Caesarea Medical Electronics , Ltd. | 2007-04-13 | 30 | 0 |
| K061325 | BODYGAURD PAIN MANAGER INFUSION SYSTEM | Caesarea Medical Electronics , Ltd. | 2006-08-24 | 105 | 1 |
| K060479 | MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM | Caesarea Medical Electronics , Ltd. | 2006-05-12 | 78 | 0 |
| K050800 | NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS | Caesarea Medical Electronics , Ltd. | 2005-11-23 | 238 | 0 |
| K042696 | BODYGUARD INFUSION PUMP SYSTEM | Caesarea Medical Electronics , Ltd. | 2005-03-11 | 162 | 39 |
| K040957 | NOA III ENTERAL NUTRITION PUMP | Caesarea Medical Electronics , Ltd. | 2004-05-21 | 38 | 0 |
| K031749 | BODYGUARD INFUSION SYSTEM | Caesarea Medical Electronics , Ltd. | 2003-08-21 | 77 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda