Smartprep Centrifuge System
FDA 510(k) K991430 · Harvest Technologies, LLC
510(k) numberK991430
Submission
- Device name
- Smartprep Centrifuge System
- Applicant
- Harvest Technologies, LLC
Norwell, MA, US - Received
- April 26, 1999
- Decision date
- May 28, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
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| 510(k) | Device | Decision |
|---|---|---|
| K121005 | Adiprep Adipose Transfer SystemMUU · Traditional | 09/21/2012SE |
| K103340 | SMARTPREP2 Bmac System, Smartprep Platelet Concentration SystemJQC · Special | 12/06/2010SE |
| K052925 | SMARTPREP2 Centrifuge SystemJQC · Traditional | 01/04/2006SE |
| K043261 | Harvest Graft Delivery SyringeFMF · Traditional | 03/11/2005SE |
| K020252 | Smartjet Grafting Liquid Applicator, Models Sk/S & LK/2FMF · Traditional | 04/05/2002SE |
| K011032 | Smartjet Bone Graft Liquid Applicator (Spray Tip), Model Sk/S, Smartjet Bone Graft…LYC · Traditional | 07/03/2001SE |
| K000456 | Harvest Technologies Dual Liquid Applicator, Model Sk/S: Harvest Dual Liquid Applicator…FMF · Traditional | 06/01/2000SE |
| K983022 | Smartcell Processing SystemCAC · Traditional | 04/02/1999SE |
Questions and answers
When was Smartprep Centrifuge System cleared by the FDA?
Smartprep Centrifuge System (K991430) received a 510(k) decision of Substantially Equivalent on May 28, 1999, 32 days after the submission was received.
What is the product code of K991430?
The FDA product code is JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.