Creative Care Systems, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Creative Care Systems, Inc.” (first 1984, latest 1986), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 61 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 3 | 3 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 1 | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 1 | 1 |
Review panels
- General Hospital (6)
- Anesthesiology (1)
Most recent Creative Care Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861406 | NON-KOR WINGED INFUSION SETS | FMI | 1986-05-06 | 21 |
| K852831 | NON-KOR ACCESS KITS | FMI | 1985-09-19 | 79 |
| K850888 | PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV | LJT | 1985-05-07 | 64 |
| K850887 | DRESSING CHANGE KIT | FOZ | 1985-05-01 | 58 |
| K841742 | NON-CORING NEEDLE | FMI | 1984-07-06 | 70 |
| K840919 | DAYPAK SYS VII CATHETER CARE KIT | KLK | 1984-04-17 | 47 |
| K840681 | DAYPAK SYSTEM III CATHETER CARE KIT | LJS | 1984-04-16 | 61 |
Recalls
openFDA lists no recalls under a recalling firm named Creative Care Systems, 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.
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.
- Creative Laboratory Products, Inc. (27 510(k)s)
- Creative Biomedics, Inc. (4 510(k)s)
- Creative Contract (M) Sdn Bhd (3 510(k)s)
- Creative Medical, Inc. (2 510(k)s)
- Creative Medical Designs, Inc. (2 510(k)s)
- Creative Research and Mfg., Inc. (2 510(k)s)
- Creative Balloons GmbH (1 510(k)s)
- Creative Design (1 510(k)s)
- Creative Design Systems, Inc. (1 510(k)s)
- Creative Fitness Developments S.L. (1 510(k)s)
- Creative Images, Inc. (1 510(k)s)
- Creative Instruments (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Creative Care Systems, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Creative Care Systems, Inc.” (first 1984, latest 1986), across 5 product codes in 2 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 Creative Care Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Creative Care Systems, Inc. is 61 days.
Which FDA product codes appear under Creative Care Systems, Inc.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 3); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1); KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia, 1).
Next steps
- See all 7 Creative Care Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Creative Care Systems, 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.