Clearmedical/Nellcor Oxisensor II, Neonatal/Adult, Model N-25
FDA 510(k) K012609 · Clearmedical, Inc.
510(k) numberK012609
Submission
- Device name
- Clearmedical/Nellcor Oxisensor II, Neonatal/Adult, Model N-25
- Applicant
- Clearmedical, Inc.
Bellevue, WA, US - Received
- August 13, 2001
- Decision date
- July 3, 2002
- 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 |
|---|---|---|
| K033579 | Reprocessed Multiple Clip AppliersNMJ · Traditional | 07/11/2005SE |
| K033578 | Reprocessed Reloadable Cutters, Staplers, and AppliersNLL · Traditional | 07/11/2005SE |
| K033591 | Reprocessed TrocarsKBG · Traditional | 06/03/2005SE |
| K033592 | Reprocessed Surgical Scissors and GraspersGEI · Traditional | 07/27/2004SE |
| K033593 | Reprocessed Single Use Devices Biopsy ForcepsNLU · Traditional | 11/20/2003SE |
| K031416 | Clearmedical/Critikon Blood Pressure Cuff; Clearmedical/Welch Allyn Blood Pressure CuffDXQ · Traditional | 07/15/2003SE |
| K012622 | Clearmedical/Nellcor Oxisensor II, Pediatric, Model D-20NLF · Traditional | 07/03/2002SE |
| K012600 | Clearmedical/Nellcor Oxisensor II, Adult, Model D-25/D-25LNLF · Traditional | 07/03/2002SE |
| K012621 | Clearmedical/Hentleigh Deep Vein Thrombosis (DVT) GarmentJOW · Traditional | 02/06/2002SE |
| K012616 | Clearmedical/Huntleigh Foot Garments; Models FG200/LRG (Large), FG200/STD (Standard)…JOW · Traditional | 02/06/2002SE |
Questions and answers
When was Clearmedical/Nellcor Oxisensor II, Neonatal/Adult, Model N-25 cleared by the FDA?
Clearmedical/Nellcor Oxisensor II, Neonatal/Adult, Model N-25 (K012609) received a 510(k) decision of Substantially Equivalent on July 3, 2002, 324 days after the submission was received.
What is the product code of K012609?
The FDA product code is NLF – Oximeter, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.2700.