Sims Deltec, Inc.: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “Sims Deltec, Inc.” (first 1995, latest 2001), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 79 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 10 | 10 |
| FPA | Set, Administration, Intravascular | 9 | 9 |
| FRN | Pump, Infusion | 7 | 7 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 | 2 |
| FPB | Filter, Infusion Line | 1 | 1 |
| MEA | Pump, Infusion, Pca | 1 | 1 |
Review panels
- General Hospital (32)
Most recent Sims Deltec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010426 | PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER | LJT | 2001-03-08 | 23 |
| K000842 | CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM | FRN | 2000-06-08 | 85 |
| K000942 | CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 | FPA | 2000-04-27 | 35 |
| K994216 | PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM | LJT | 2000-01-27 | 43 |
| K992697 | PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM | LJT | 1999-11-18 | 99 |
| K992880 | P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM | LJT | 1999-10-19 | 53 |
| K991599 | CADD ADMINISTRATION SET | FPA | 1999-06-15 | 36 |
| K991301 | CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 | FPA | 1999-06-09 | 54 |
| K991255 | CADD-TPN ADMINISTRATION SET, MODEL 21-7071 | FPA | 1999-06-09 | 57 |
| K990083 | CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER | FPA | 1999-02-12 | 32 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sims Deltec, Inc..
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 Sims Deltec, Inc. (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)
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.
- Sims Portex, Inc. (12 510(k)s)
- Sims Portex , Ltd. (4 510(k)s)
- Sims Surgical, Inc. (3 510(k)s)
- Sims (2 510(k)s)
- Sims Level 1, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sims Deltec, Inc.?
FDA lists 32 510(k) clearances under the applicant name “Sims Deltec, Inc.” (first 1995, latest 2001), across 7 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 Sims Deltec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sims Deltec, Inc. is 79 days.
Which FDA product codes appear under Sims Deltec, Inc.?
The most frequent FDA product codes under this applicant name are LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 10); FPA (Set, Administration, Intravascular, 9); FRN (Pump, Infusion, 7).
Next steps
- See all 32 Sims Deltec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJT, Sims 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 (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.