Deltec, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Deltec, Inc.” (first 2002, latest 2003), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 55 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under ICU Medical, based on public ownership records.
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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 2 | 2 |
| LZG | Pump, Infusion, Insulin | 1 | 1 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 1 | 1 |
| MSD | Catheter, Hemodialysis, Implanted | 1 | 1 |
Review panels
Most recent Deltec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031361 | CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP | FPA | 2003-05-23 | 23 |
| K030983 | TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY | MSD | 2003-04-25 | 28 |
| K022221 | TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS | MPB | 2003-01-30 | 205 |
| K021999 | GRIPPER PLUS NEEDLE | FPA | 2002-08-13 | 55 |
| K020655 | DELTEC INSULIN INFUSION PUMP AND ACCESSORIES | LZG | 2002-08-13 | 165 |
Recalls
28 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2004-03-29.
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 Deltec, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZG)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZG)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Deltec Systems, Inc. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Deltec, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Deltec, Inc.” (first 2002, latest 2003), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Deltec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Deltec, Inc. is 55 days.
Which FDA product codes appear under Deltec, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 2); LZG (Pump, Infusion, Insulin, 1); MPB (Catheter, Hemodialysis, Non-Implanted, 1).
Next steps
- See all 5 Deltec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Deltec, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.