Pain Care 2000L
FDA 510(k) K002321 · Breg, Inc.
510(k) numberK002321
Submission
- Device name
- Pain Care 2000L
- Applicant
- Breg, Inc.
Vista, CA, US - Received
- July 31, 2000
- Decision date
- August 14, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MEB – Pump, Infusion, Elastomeric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K131249 | On-Q Painbuster, On-Q C-Bloc, Homepump Eclipse, Homepump C-SeriesMEB · Traditional | I-Flow, LLC | 02/03/2014SE |
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| K090300 | Modification to AutofuserMEB · Special | Ace Medical Us, LLC | 04/30/2009SE |
| K081905 | Accuflow and Accuflux Elastomeric Infusion PumpMEB · Traditional | Westmed, Inc. | 07/15/2008SE |
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More from Advanced Infusion, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K183702 | Polar Care WaveIRP · Traditional | 03/01/2019SE |
| K070402 | Modification to Polar Care 500ILO · Special | 03/29/2007SE |
| K041714 | E-Pain CareFRN · Traditional | 10/01/2004SE |
| K020988 | Pain Care 4200MEB · Special | 04/04/2002SE |
| K013928 | Pain Care 3200MEB · Special | 12/03/2001SE |
| K003611 | Pain Care Multi-Port Catheter, Model 2000LFRN · Special | 12/13/2000SE |
| K002073 | Pain Care 3000MEB · Traditional | 09/19/2000SE |
| K983454 | Pain Care 2000MEB · Traditional | 12/16/1998SE |
| K963596 | Polar Care 300ILO · Traditional | 12/04/1996SE |
| K961855 | Polar Care (Model 500/50000)ILO · Traditional | 08/09/1996SE |
Questions and answers
When was Pain Care 2000L cleared by the FDA?
Pain Care 2000L (K002321) received a 510(k) decision of Substantially Equivalent on August 14, 2000, 14 days after the submission was received.
What is the product code of K002321?
The FDA product code is MEB – Pump, Infusion, Elastomeric, a Class II (moderate risk) device regulated under 21 CFR 880.5725.