Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332A
FDA 510(k) K041152 · Applied Diabetes Research, Inc.
510(k) numberK041152
Submission
- Device name
- Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332A
- Applicant
- Applied Diabetes Research, Inc.
Dana Point, CA, US - Received
- May 3, 2004
- Decision date
- May 24, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
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| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | Iradimed Corporation | 05/28/2025SE |
| K243855 | BD Alaris Infusion System with Guardrails Suite MXFRN · Traditional | Carefusion 303, Inc. | 04/25/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
More from Deka Research and Development Corp.
Questions and answers
When was Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332A cleared by the FDA?
Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332A (K041152) received a 510(k) decision of Substantially Equivalent on May 24, 2004, 21 days after the submission was received.
What is the product code of K041152?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.