Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Deltec Systems, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
86 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871132 | PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS | Deltec Systems, Inc. | 1987-04-20 | 31 | 6 |
| K870768 | AC ADAPTER ACCESSORY, PRODUCT CODE 600123A | Deltec Systems, Inc. | 1987-03-13 | 15 | 0 |
| K862927 | CADD-1, MODEL 5100 HF | Deltec Systems, Inc. | 1986-08-27 | 26 | 0 |
| K854964 | CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES. | Deltec Systems, Inc. | 1986-03-07 | 86 | 0 |
| K853584 | CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMP | Deltec Systems, Inc. | 1985-11-12 | 78 | 0 |
| K850183 | CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M | Deltec Systems, Inc. | 1985-03-13 | 54 | 0 |
| K843772 | CADD-1 5100 AMBULATORY INFUSION PUMP | Deltec Systems, Inc. | 1984-12-06 | 72 | 8 |
| K843773 | CADD-PAC 5200 AMBULATORY INFUSION PUMP | Deltec Systems, Inc. | 1984-12-06 | 72 | 0 |
| K833949 | MICRO INFUSION SET | Deltec Systems, Inc. | 1984-01-11 | 57 | 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