FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
K Number: K110723
·
Decision Jul 28, 2011
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
26
Applicant Total
85
Review Days
134
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
- K Number
- K110723
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Masimo Corporation
- Date Received
- March 16, 2011
- Decision Date
- July 28, 2011
- Product Code
- NLF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NLF | Oximeter, Reprocessed | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NLF), ordered by most recent decision date.
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)
FDA 510(k)
FDA Class 2
·Cardiovascular
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)
FDA 510(k)
FDA Class 2
·Cardiovascular
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)
FDA 510(k)
FDA Class 2
·Cardiovascular
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
FDA 510(k)
FDA Class 2
·Cardiovascular
Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
FDA 510(k)
FDA Class 2
·Cardiovascular
RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Masimo Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K254209 | Radius VSM and Accessories | Jun 4, 2026 | Substantially Equivalent |
| K243324 | Masimo O3 Regional Oximeter | Jul 17, 2025 | Substantially Equivalent |
| K250757 | Radius VSM and Accessories | May 29, 2025 | Substantially Equivalent |
| K243305 | Masimo W1 | Apr 3, 2025 | Substantially Equivalent |
| K240229 | Masimo W1 | Aug 8, 2024 | Substantially Equivalent |
| K234021 | Masimo Stork | May 3, 2024 | Substantially Equivalent |
| K214115 | MightySat -OTC | Jan 31, 2024 | Substantially Equivalent |
| K223721 | Masimo Stork | Dec 15, 2023 | Substantially Equivalent |
| K232512 | Masimo W1 | Nov 17, 2023 | Substantially Equivalent |
| DEN200076 | ORi | Oct 12, 2023 | Unknown |