Molded Products, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Molded Products, Inc.” (first 1993, latest 2002), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 266 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 |
|---|---|---|---|
| FID | Tubing, Dialysate | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| FIB | Protector, Transducer, Dialysis | 1 | 1 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 | 1 |
Review panels
Most recent Molded Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022068 | TUBING, DIALYSATE (AND CONNECTOR) | FID | 2002-09-23 | 90 |
| K010366 | DISPOSABLE STORAGE CAP | FJI | 2001-11-28 | 294 |
| K010712 | DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES | FID | 2001-09-27 | 202 |
| K003712 | MODIFICATION TO MALE TO MALE LUER ADAPTER | KOC | 2001-05-16 | 166 |
| K925978 | MPC-80 TRANSDUCER | FIB | 1994-01-14 | 415 |
| K925930 | MPC-150 MALE TO MALE LUER ADAPTER | FPA | 1993-08-16 | 266 |
| K925927 | MPC-1000 INJECTION CAP/PLUG | FPA | 1993-08-16 | 266 |
Recalls
4 product recalls in 4 recall events; 1 initiated in the last five years. Most recent: 2026-02-17.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Molded Products, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Molded Products, Inc.” (first 1993, latest 2002), 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 Molded Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Molded Products, Inc. is 266 days.
Which FDA product codes appear under Molded Products, Inc.?
The most frequent FDA product codes under this applicant name are FID (Tubing, Dialysate, 2); FPA (Set, Administration, Intravascular, 2); FIB (Protector, Transducer, Dialysis, 1).
Next steps
- See all 7 Molded Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FID, Molded Products, 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.