Oxisensor II Recycled Sensor and Oximax Recycled Sensor
FDA 510(k) K033973 · Nellcor Puritan Bennett, Inc.
510(k) numberK033973
Submission
- Device name
- Oxisensor II Recycled Sensor and Oximax Recycled Sensor
- Applicant
- Nellcor Puritan Bennett, Inc.
Pleasanton, CA, US - Received
- December 22, 2003
- Decision date
- December 13, 2004
- 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 |
|---|---|---|
| K070899 | Puritan Bennett Legendair XL2CBK · Traditional | 12/13/2007SE |
| K070408 | Duramax Reusable Oximetry SensorDQA · Abbreviated | 05/25/2007SE |
| K060576 | Nellcor Oximax N-600X Pulse OximeterDQA · Traditional | 08/14/2006SE |
| K051271 | Oximax Neomax Adhesive Forehead Reflectance Oximetry SensorDQA · Traditional | 01/10/2006SE |
| K052186 | Nellcor Oximax Pulse Oximetry Sensons (Max-A, Max-Al, Max-N, Max-I, Max-PDQA · Special | 11/10/2005SE |
| K051352 | Oximax NPB-40 Handheld Pulse OximeterDQA · Traditional | 08/11/2005SE |
| K050072 | Goodknight 425STBZD · Special | 06/13/2005SE |
| K030787 | Shiley Flextra Tracheostomy TubeJOH · Traditional | 11/14/2003SE |
| K030930 | Oximax Softcare Sensors, Models Sc-A, Sc-Pr, Sc-Neo, Sc-NDQA · Traditional | 05/23/2003SE |
| K023494 | Nellcor Indgo Manual ResuscitatorBTM · Special | 02/07/2003SE |
Questions and answers
When was Oxisensor II Recycled Sensor and Oximax Recycled Sensor cleared by the FDA?
Oxisensor II Recycled Sensor and Oximax Recycled Sensor (K033973) received a 510(k) decision of Substantially Equivalent on December 13, 2004, 357 days after the submission was received.
What is the product code of K033973?
The FDA product code is NLF – Oximeter, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.2700.