ORS-1000LD
FDA 510(k) K021288 · O.R. Solutions, Inc.
510(k) numberK021288
Submission
- Device name
- ORS-1000LD
- Applicant
- O.R. Solutions, Inc.
Chantilly, VA, US - Received
- April 23, 2002
- Decision date
- June 27, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LHC – Warmer, Irrigation Solution
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5950
- Specialty
- Physical Medicine
Other 510(k)s with product code LHC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153713 | Getinge Series Warming CabinetLHC · Traditional | Getinge Sourcing, LLC | 06/07/2016SE |
| K152522 | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesLHC · Special | Ecolab, Inc. | 01/15/2016SE |
| K150190 | IntraTemp Solution WarmerLHC · Special | Ecolab, Inc. | 02/26/2015SE |
| K142173 | Non-Sterile ORS-400N Scope Pillow Warmer DrapeLHC · Traditional | Ecolab, Inc. | 12/30/2014SE |
| K142080 | Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid…LHC · Special | Ecolab, Inc. | 08/28/2014SE |
| K083417 | Intratemp Solution WarmerLHC · Traditional | C Change Surgical, LLC | 01/13/2009SE |
| K080609 | Swc/Dwc Warming CabinetsLHC · Traditional | Mac Medical | 06/13/2008SE |
| K051819 | C Change Solution WarmerLHC · Traditional | C Change Surgical, LLC | 08/15/2005SE |
| K023283 | 1075LD Hush-SlushLHC · Traditional | O.R. Solutions, Inc. | 11/13/2002SE |
| K023282 | ORS-3000LDLHC · Traditional | O.R. Solutions, Inc. | 11/13/2002SE |
More from O.R. Solutions, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K051979 | Ors Model 6000 Endoscope HolderOCT · Special | 08/30/2005SE |
| K023283 | 1075LD Hush-SlushLHC · Traditional | 11/13/2002SE |
| K023282 | ORS-3000LDLHC · Traditional | 11/13/2002SE |
| K021289 | Warmer 2000LDLHC · Traditional | 06/26/2002SE |
| K960836 | DMS-9000LRJ · Traditional | 09/12/1996SE |
| K953654 | ORS-111KKX · Traditional | 09/22/1995SE |
Questions and answers
When was ORS-1000LD cleared by the FDA?
ORS-1000LD (K021288) received a 510(k) decision of Substantially Equivalent on June 27, 2002, 65 days after the submission was received.
What is the product code of K021288?
The FDA product code is LHC – Warmer, Irrigation Solution, a Class I (low risk) device regulated under 21 CFR 890.5950.