NLF — Oximeter, Reprocessed Class II
FDA product code NLF covers "Oximeter, Reprocessed", a Class II medical device regulated under 21 CFR 870.2700. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NLF
- Device Class
- Class II
- Regulation Number
- 870.2700
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241758 | stryker sustainability solutions | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pul | October 22, 2024 |
| K222019 | stryker sustainability solutions | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Puls | December 4, 2022 |
| K211138 | stryker sustainability solutions | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-2 | March 8, 2022 |
| K201699 | surgical instrument and savings inc (dba medline renewal) | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor | July 22, 2020 |
| K191018 | surgical instrument service and savings | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive | July 3, 2019 |
| K111773 | renu medical | RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE | November 16, 2011 |
| K110723 | masimo corporation | M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS | July 28, 2011 |
| K102560 | sterilmed | REPROCESSED PULSE OXIMETER SENSORS | February 18, 2011 |
| K101280 | midwest reprocessing center | MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE | October 7, 2010 |
| K092368 | sterilmed | REPROCESSED PULSE OXIMETER SENSORS | November 3, 2009 |
| K083719 | masimo corporation | LNCS OXIMETRY SENSORS | July 30, 2009 |
| K081927 | renu medical | RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO | February 6, 2009 |
| K081238 | ascent healthcare solutions | REPROCESSED MASIMO PULSE OXIMETER SENSORS | July 29, 2008 |
| K080424 | hygia health services | HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1 | May 28, 2008 |
| K072194 | renu medical | RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 | November 29, 2007 |
| K063661 | renu medical | RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 | May 25, 2007 |
| K042891 | datex-ohmeda | DATEX-OHMEDA OXY-AFR SENSOR | June 29, 2005 |
| K042316 | vanguard medical concepts | VANGUARD REPROCESSED PULSE OXIMETER SENSORS | January 6, 2005 |
| K033973 | nellcor puritan bennett | OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR | December 13, 2004 |
| K041127 | sterilmed | MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS | September 23, 2004 |