Palm Pump
FDA 510(k) K002434 · Sorenson Medical, Inc.
510(k) numberK002434
Submission
- Device name
- Palm Pump
- Applicant
- Sorenson Medical, Inc.
West Jordan, UT, US - Received
- August 9, 2000
- Decision date
- August 23, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MEA – Pump, Infusion, Pca
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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|---|---|---|---|
| K162165 | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent…MEA · Traditional | Summit Medical Products, Inc. | 08/29/2017SE |
| K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion…MEA · Traditional | Smiths Medical Ads, Inc. | 08/24/2017SE |
| K143612 | LifeCare PCA Infusion SystemMEA · Traditional | Hospira, Inc. | 04/08/2016SE |
| K130394 | Cadd -Solis Ambulatory Infusion Pump, Version 3.0MEA · Traditional | Smiths Medical Asd, Inc. | 12/09/2013SE |
| K092313 | Perfusor Space Infusion Syringe Pump SystemMEA · Traditional | B.Braun Medical, Inc. | 11/04/2009SE |
| K072144 | Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software -…MEA · Traditional | Smiths Medical MD, Inc. | 03/07/2008SE |
| K051253 | Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with…MEA · Traditional | Baxter Healthcare Corp | 07/15/2005SE |
| K043299 | Medley Pca Module, Model 8120MEA · Traditional | Alaris Medical Systems, Inc. | 12/10/2004SE |
| K043256 | Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System…MEA · Special | Hospira, Inc. | 12/06/2004SE |
| K042800 | Lifecare Pca Infusion System with Hospira Mednet SoftwareMEA · Traditional | Hospira, Inc. | 10/18/2004SE |
More from Hospira, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K052221 | Ambit Push & Play Ambulatory Infusion PumpFRN · Abbreviated | 12/08/2005SE |
| K033425 | Ambit Intermittent Ambulatory Infusion PumpFRN · Special | 11/06/2003SE |
| K033325 | Ambit Continuous Ambulatory Infusion PumpFRN · Special | 11/06/2003SE |
| K001287 | Empty Reservoir Bag, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 MLKPE · Traditional | 06/09/2000SE |
| K991363 | 30 Pump, Continuous Low Flow, 200 Pump, Intermittent with Kvo or Continuous, Pca Pump…FRN · Special | 05/13/1999SE |
Questions and answers
When was Palm Pump cleared by the FDA?
Palm Pump (K002434) received a 510(k) decision of Substantially Equivalent on August 23, 2000, 14 days after the submission was received.
What is the product code of K002434?
The FDA product code is MEA – Pump, Infusion, Pca, a Class II (moderate risk) device regulated under 21 CFR 880.5725.