Modification to: Reprocessed Oximax Pulse Oximeter Sensors
FDA 510(k) K041127 · Sterilmed, Inc.
510(k) numberK041127
Submission
- Device name
- Modification to: Reprocessed Oximax Pulse Oximeter Sensors
- Applicant
- Sterilmed, Inc.
Maple Grove, MN, US - Received
- April 30, 2004
- Decision date
- September 23, 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 |
|---|---|---|
| K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…OWQ · Traditional | 06/29/2026SE |
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…NLH · Traditional | 10/11/2024SE |
| K190478 | Reprocessed ViewFlex Xtra ICE CatheterOWQ · Traditional | 11/14/2019SE |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional | 08/15/2019SE |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ · Traditional | 04/15/2019SE |
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…OWQ · Traditional | 11/21/2016SE |
| K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…NUJ · Traditional | 09/20/2016SE |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterNLH · Traditional | 06/23/2016SE |
| K152090 | Reprocessed Steerable IntroducerPNE · Traditional | 03/23/2016SE |
| K152134 | Reprocessed Vessel SealerNUJ · Traditional | 01/15/2016SE |
Questions and answers
When was Modification to: Reprocessed Oximax Pulse Oximeter Sensors cleared by the FDA?
Modification to: Reprocessed Oximax Pulse Oximeter Sensors (K041127) received a 510(k) decision of Substantially Equivalent on September 23, 2004, 146 days after the submission was received.
What is the product code of K041127?
The FDA product code is NLF – Oximeter, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.2700.