Percupump (TM)
FDA 510(k) K864227 · E-Z-Em, Inc.
510(k) numberK864227
Submission
- Device name
- Percupump (TM)
- Applicant
- E-Z-Em, Inc.
Westbury, NY, US - Received
- October 28, 1986
- Decision date
- January 16, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code FRN
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|---|---|---|---|
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionFRN · Traditional | Deka R&D Corp | 07/24/2026SE |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingFRN · Traditional | Koru Medical Systems, Inc. | 01/28/2026SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K071378 | Modification to Empower Ct/Cta Injector System, Models 9800/9900 Product SeriesJAK · Special | 06/13/2007SE |
| K062449 | Empowermr Injector System, Model 9730IZQ · Abbreviated | 04/13/2007SE |
| K063029 | Empower Ct/Cta Injector System, Model 9800/9900JAK · Special | 11/02/2006SE |
| K053008 | E-Z-Em Endoscopic CO2 RegulatorFCX · Abbreviated | 12/27/2005SE |
| K041178 | Empower Transfer Set, (Cat. No. 7725)FPK · Traditional | 07/16/2004SE |
| K031571 | Empowercta Injector System, Models 9930 & 9910 & 9825IZQ · Special | 06/19/2003SE |
| K030854 | PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400FCX · Special | 04/16/2003SE |
| K013219 | PROTOCO2L Insufflator Model 6400FCX · Abbreviated | 02/19/2002SE |
| K011160 | E-Z Em Percupump 2001 CT InjectorJAK · Special | 05/16/2001SE |
| K974621 | Percupump II with EdaDSB · Traditional | 01/27/1998SE |
Questions and answers
When was Percupump (TM) cleared by the FDA?
Percupump (TM) (K864227) received a 510(k) decision of Substantially Equivalent on January 16, 1987, 80 days after the submission was received.
What is the product code of K864227?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.