Luer Lock Adapter/Nut
FDA 510(k) K862653 · Mallinckrodt Critical Care
510(k) numberK862653
Submission
- Device name
- Luer Lock Adapter/Nut
- Applicant
- Mallinckrodt Critical Care
St Louis, MO, US - Received
- July 14, 1986
- Decision date
- July 31, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
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More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880343 | Burney Gallbladder Catheter KitFGE · Traditional | 05/01/1989SE |
| K874605 | Hi-Lo Temp(R) Myocardial Temperature SensorKRI · Traditional | 02/02/1988SE |
| K874514 | Hi-Lo Temp(R) General Purpose Temperature ProbeFLL · Traditional | 01/29/1988SE |
| K874568 | Hi-Lo Temp(R) Model 8700 Patient Temp MonitorFLL · Traditional | 01/06/1988SE |
| K874404 | Hi-Lo Temp(R) Skin Temperature SensorFLL · Traditional | 11/06/1987SE |
| K873461 | Laser-Flex(Tm) Tracheal Tube (Cuffed)BTR · Traditional | 11/06/1987SE |
| K873833 | Thermocouple AdapterFLL · Traditional | 11/03/1987SE |
| K873004 | Guiding CatheterDQO · Traditional | 09/15/1987SE |
| K871204 | Cuffed Tracheal Tube (Multiple)BTR · Traditional | 04/21/1987SE |
| K862666 | Uncuffed Laser Resisteant Tracheal Tube(Tentative)BTR · Traditional | 08/01/1986SE |
Questions and answers
When was Luer Lock Adapter/Nut cleared by the FDA?
Luer Lock Adapter/Nut (K862653) received a 510(k) decision of Substantially Equivalent on July 31, 1986, 17 days after the submission was received.
What is the product code of K862653?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.