MOLDED PRODUCTS INC.
Registration 1932668FEI 1000138417HARLAN, IA
Owner/operator: MOLDED PRODUCTS INC.
- Complaint File Establishment per 21 CFR 820.198
- Manufacture Medical Device
- Manufacture Medical Device for Another Party (Contract Manufacturer)
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 22
- Added, last 12 months
- 0
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 22
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| KOC | Male DIN to Male DIN Luer Adapter Lines Includes MPC-850, -825S, -660S, -800, -875Accessories, Blood Circuit, Hemodialysis | Class 2 | 21 CFR 876.5820 | K003712 |
| GBM | Female Urethra Catheterization - Assisting Device Includes FS-1700Catheter, Urethral | Class 2 | 21 CFR 876.5130 | — |
| LKY | MedErect Vacuum Therapy SystemDevice, External Penile Rigidity | Class 2 | 21 CFR 876.5020 | — |
| LIF | ASSIST HEADER CLEANER Includes MPC-50910, -50911, -50912Dialyzer Reprocessing System | Class 2 | 21 CFR 876.5820 | K043126 |
| FJI | Disposable Storage Caps Includes MPC-60B, -60D, -50DV, -40, -45Dialyzer, Capillary, Hollow Fiber | Class 2 | 21 CFR 876.5820 | K010366 |
| FIB | TRANSDUCER PROTECTOR, DIALYSIS, Includes MPC-80, -85Protector, Transducer, Dialysis | Class 2 | 21 CFR 876.5820 | K925978 |
| FPA | LUER TO LUER ADAPTER, Includes MPC-150, -155, -160Set, Administration, Intravascular | Class 2 | 21 CFR 880.5440 | K925930 |
| FPA | INJECTION LUER CAPS/PLUGS, Includes MPC-100, -124, -115, -123, -135Set, Administration, Intravascular | Class 2 | 21 CFR 880.5440 | K925927 |
| FID | DIALYSATE TUBING W/ HANSEN CONNECTORS Includes MPC-725, -740Tubing, Dialysate | Class 2 | 21 CFR 876.5820 | K022068 |
| FID | Re-Use/Wash-Out Lines w/connectors Includes MPC-660, -640, -720, -710, -620, -715, -650, -705, -700Tubing, Dialysate | Class 2 | 21 CFR 876.5820 | K010712 |
| LYU | Safety Visor & 2 Shields Includes MPC-305Accessory, Surgical Apparel | Class 1 | 21 CFR 878.4040 | — |
| HXD | FISTULA PRESSURE DRESSING CLAMP, Includes MPC-260, -260B, -250, -250XLClamp | Class 1 | 21 CFR 878.4800 | — |
and 10 more on your full dossier
What changed
Nothing added in the last twelve months, and no change seen on the record yet.