Reprocessed Masimo Pulse Oximeter Sensors
FDA 510(k) K081238 · Ascent Healthcare Solutions
510(k) numberK081238
Submission
- Device name
- Reprocessed Masimo Pulse Oximeter Sensors
- Applicant
- Ascent Healthcare Solutions
Phoenix, AZ, US - Received
- May 1, 2008
- Decision date
- July 29, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NLF – Oximeter, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Other 510(k)s with product code NLF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…NLF · Traditional | Stryker Sustainability Solutions | 10/22/2024SE |
| K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…NLF · Traditional | Stryker Sustainability Solutions | 12/04/2022SE |
| K211138 | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L)…NLF · Traditional | Stryker Sustainability Solutions | 03/08/2022SE |
| K201699 | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 SensorNLF · Special | Surgical Instrument and Savings Inc (Dba Medline… | 07/22/2020SE |
| K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsNLF · Traditional | Surgical Instrument Service and Savings, Inc. | 07/03/2019SE |
| K111773 | Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and NeonateNLF · Traditional | Renu Medical, Inc. | 11/16/2011SE |
| K110723 | M-Lncs Oximetry Sensors, Reprocessed M-Lncs Oximetry SensorsNLF · Special | Masimo Corporation | 07/28/2011SE |
| K102560 | Reprocessed Pulse Oximeter SensorsNLF · Traditional | Sterilmed, Inc. | 02/18/2011SE |
| K101280 | Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeNLF · Traditional | Midwest Reprocessing Center, LLC | 10/07/2010SE |
| K092368 | Reprocessed Pulse Oximeter SensorsNLF · Traditional | Sterilmed, Inc. | 11/03/2009SE |
More from Sterilmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K111600 | Reprocessed Hand Activate Sealer/DividerNUJ · Traditional | 11/15/2011SE |
| K110189 | Reprocessed Electrosurgical InstrumentNUJ · Traditional | 07/18/2011SE |
| K100909 | Reprocessed Compression SleevesJOW · Traditional | 07/23/2010SE |
| K100254 | Reprocessed CS Bi-Diectional Diagnostic Electrophysiology CatheterNLH · Traditional | 05/28/2010SE |
| K100537 | Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9…NLQ · Traditional | 05/12/2010SE |
| K100080 | Reprocessed Trocars, Model B5LT and CB5LTNLM · Traditional | 03/19/2010SE |
| K093702 | Reprocessed Ultrasonic Coagulating ShearsNLQ · Traditional | 03/04/2010SE |
| K092425 | Reprocessed 3D Diagnostic Ultrasound Catheters, Model SNDSTR10OWQ · Traditional | 10/21/2009SE |
| K090323 | Reprocessed Electrophysiology CathetersNLH · Traditional | 04/01/2009SE |
| K082023 | Reprocessed Electrophysiology CathetersNLH · Traditional | 09/16/2008SE |
Questions and answers
When was Reprocessed Masimo Pulse Oximeter Sensors cleared by the FDA?
Reprocessed Masimo Pulse Oximeter Sensors (K081238) received a 510(k) decision of Substantially Equivalent on July 29, 2008, 89 days after the submission was received.
What is the product code of K081238?
The FDA product code is NLF – Oximeter, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.2700.