Data / Medical devices / United States / Molded Products Inc.
Molded Products Inc.: FDA-registered device maker in Harlan, IA, United States, 8 510(k) clearances
Molded Products Inc. is registered with the FDA (registration 1932668) in Harlan, IA, United States. It lists 20 device types. The FDA files 8 510(k) clearances under its listings, the newest dated February 3, 2005. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1932668
- FEI number
- 1000138417
- Address
- 1812 Industrial Pkwy, Harlan, IA, United States, 51537
- Owner or operator
- MOLDED PRODUCTS INC. (9007334)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- November 30, 1993
- Registered through
- 2026
- Brand names listed
- "ENCASE" FISTULA NEEDLE ENCAP HOLDER, Includes MPC-375, ASSIST HEADER CLEANER Includes MPC-50910, -50911, -50912, Collection Assist Device Includes MPC-745, DIALYSATE TUBING W/ HANSEN CONNECTORS Includes MPC-725, -740, Dialyzer Holder Includes MPC-1405, -1415, -1425, Disposable Storage Caps Includes MPC-60B, -60D, -50DV, -40, -45, E-Z Grip Includes MPC-950, FISTULA PRERSSURE DRESSING STRAP/TOURNIQUET, Includes MPC-350 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 3, 2005 | K043126 | ASSIST HEADER CLEANER | LIF | Substantially Equivalent | Alcavis International, Inc. | accessdata.fda.gov |
| September 23, 2002 | K022068 | TUBING, DIALYSATE (AND CONNECTOR) | FID | Substantially Equivalent | Molded Products, Inc. | accessdata.fda.gov |
| November 28, 2001 | K010366 | DISPOSABLE STORAGE CAP | FJI | Substantially Equivalent | Molded Products, Inc. | accessdata.fda.gov |
| September 27, 2001 | K010712 | DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES | FID | Substantially Equivalent | Molded Products, Inc. | accessdata.fda.gov |
| May 16, 2001 | K003712 | MODIFICATION TO MALE TO MALE LUER ADAPTER | KOC | Substantially Equivalent | Molded Products, Inc. | accessdata.fda.gov |
| January 14, 1994 | K925978 | MPC-80 TRANSDUCER | FIB | Substantially Equivalent | Molded Products, Inc. | accessdata.fda.gov |
| August 16, 1993 | K925930 | MPC-150 MALE TO MALE LUER ADAPTER | FPA | Substantially Equivalent | Molded Products, Inc. | accessdata.fda.gov |
| August 16, 1993 | K925927 | MPC-1000 INJECTION CAP/PLUG | FPA | Substantially Equivalent | Molded Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 17, 2026 | 98469 | Class II | Ongoing | See Luer Cap Set, MPC-130, set, administration, intravascular | Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached. | accessdata.fda.gov |
| June 10, 2019 | 83330 | Class II | Terminated | Luer Lock Set - Catalog # MPC-125, for IV administration sets. | Mislabeling - Some unit of sale packages (bags of 100 sets of MPC-125) were found to be incorrectly labeled as Molded Products Male to Male Luer Adapters, Catalog # MPC-150. | accessdata.fda.gov |
| January 20, 2015 | 76760 | Class II | Terminated | Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer. | A customer relayed a complaint of a leaking dialysis tubing connector. | accessdata.fda.gov |
| June 19, 2012 | 64471 | Class II | Terminated | Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing. | The recalled product leaks at the connection site. | accessdata.fda.gov |
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Updated April 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.