Product code NLF— Cardiovascular
REPROCESSED PULSE OXIMETER SENSORS
- Classification name
- Oximeter, Reprocessed
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Total cleared
- 27
- First cleared
- Most recent
FDA classification 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).”
Market context for product code NLF
FDA has cleared devices under product code NLF between 2002 and 2024, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2022
- 2020
- 2019
- 2011
- 2010
- 2009
- 2008
- 2007
- 2005
- 2004
- 2003
- 2002
Top applicants under product code NLF
Recent clearances under product code NLF
- K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000) +3 more
- K222019 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
- K211138 — Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)
- K201699 — Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
- K191018 — Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
- K111773 — RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
- K110723 — M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
- K102560 — REPROCESSED PULSE OXIMETER SENSORS
- K101280 — MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE
- K092368 — REPROCESSED PULSE OXIMETER SENSORS
- K083719 — LNCS OXIMETRY SENSORS
- K081927 — RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO
- K081238 — REPROCESSED MASIMO PULSE OXIMETER SENSORS
- K080424 — HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861
- K072194 — RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25
- K063661 — RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20
- K042891 — DATEX-OHMEDA OXY-AFR SENSOR
- K042316 — VANGUARD REPROCESSED PULSE OXIMETER SENSORS
- K033973 — OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
- K041127 — MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS
- K041867 — HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N
- K012715 — HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II
- K012677 — REPROCESSED PULSE OXIMETER SENSORS
- K012344 — VANGUARD REPROCESSED PULSE OXIMETER SENSORS
- K012600 — CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L
- K012609 — CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25
- K012622 — CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20
Data sourced from openFDA. This site is unofficial and independent of the FDA.