Modification to Male to Male Luer Adapter
FDA 510(k) K003712 · Molded Products, Inc.
510(k) numberK003712
Submission
- Device name
- Modification to Male to Male Luer Adapter
- Applicant
- Molded Products, Inc.
Harlan, IA, US - Received
- December 1, 2000
- Decision date
- May 16, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KOC – Accessories, Blood Circuit, Hemodialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | Nikkiso Co., Ltd. | 05/15/2025SE |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | Nikkiso Co., Ltd. | 05/15/2025SE |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-EKOC · Traditional | Nikkiso Co., Ltd. | 07/28/2023SE |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for…KOC · Traditional | Nikkiso Co., Ltd. | 06/16/2023SE |
| K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated…KOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 09/18/2020SE |
| K172238 | CAREline Airless Hemodialysis Blood Tubing SetsKOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 12/14/2017SE |
| K160749 | CRIT-LINE III Blood Chamber IIKOC · Special | Fresenius Medical Care Renal Therapies Group, LLC | 04/15/2016SE |
| K152953 | Crit-Line Clip (Clic) Blood ChamberKOC · Special | Fresenius Medical Care North America | 11/05/2015SE |
| K141997 | Crit-Line IV SystemKOC · Traditional | Fresenius Medical Care | 04/01/2015SE |
| K141281 | Crit-Line Clip (Clic) Blood ChamberKOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 08/14/2014SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K022068 | Tubing, Dialysate (and Connector)FID · Traditional | 09/23/2002SE |
| K010366 | Disposable Storage CapFJI · Abbreviated | 11/28/2001SE |
| K010712 | Dialysate Line with Connectors/Re-Use Wash-Out LinesFID · Abbreviated | 09/27/2001SE |
| K925978 | MPC-80 TransducerFIB · Traditional | 01/14/1994SE |
| K925930 | MPC-150 Male to Male Luer AdapterFPA · Traditional | 08/16/1993SE |
| K925927 | MPC-1000 Injection Cap/PlugFPA · Traditional | 08/16/1993SE |
Questions and answers
When was Modification to Male to Male Luer Adapter cleared by the FDA?
Modification to Male to Male Luer Adapter (K003712) received a 510(k) decision of Substantially Equivalent on May 16, 2001, 166 days after the submission was received.
What is the product code of K003712?
The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.