510(k) Report

FDA applicant

Molded Products, Inc.

Harlan, IA7 decisions1993–20024 recalls

FDA records 7 decisions for Molded Products, Inc. (Harlan, IA) from 1993 to 2002: 7 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FID (Tubing, Dialysate). 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Molded Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Molded Products, Inc. since 2007.

Recalls per year

1in 2026

2012: 12015: 12019: 12026 (partial year): 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Molded Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FPASet, Administration, Intravascular2decisions
  • FIDTubing, Dialysate2decisions
  • FJIDialyzer, Capillary, Hollow Fiber1decision
  • KOCAccessories, Blood Circuit, Hemodialysis1decision
  • FIBProtector, Transducer, Dialysis1decision

What has FDA decided for it lately?

  • K022068Tubing, Dialysate (and Connector)Molded Products, Inc. · 2002
  • K010366Disposable Storage CapMolded Products, Inc. · 2001
  • K010712Dialysate Line with Connectors/RE-Use Wash-Out LinesMolded Products, Inc. · 2001
  • K003712Modification to Male to Male Luer AdapterMolded Products, Inc. · 20012 recalls
  • K925978MPC-80 TransducerMolded Products, Inc. · 1994
  • K925930MPC-150 Male to Male Luer AdapterMolded Products, Inc. · 1993
  • K925927MPC-1000 Injection Cap/PlugMolded Products, Inc. · 19932 recalls

All 7 as Molded Products, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K925927See Luer Cap Set, MPC-130, set, administration, intravascularFeb 17, 2026Class II
  • K925927Luer Lock Set - Catalog # MPC-125, for IV administration sets.Jun 10, 2019Class II
  • K003712Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting…Jan 20, 2015Class II
  • K003712Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with…Jun 19, 2012Class II