Hygia Health Services Reprocessed Nellcot D-25 Oxisensor II
FDA 510(k) K012715 · Hygia Health Services, Inc.
510(k) numberK012715
Submission
- Device name
- Hygia Health Services Reprocessed Nellcot D-25 Oxisensor II
- Applicant
- Hygia Health Services, Inc.
Birmingham, AL, US - Received
- August 14, 2001
- Decision date
- August 1, 2003
- 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 |
|---|---|---|
| K100523 | Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model…NMD · Traditional | 05/04/2010SE |
| K090074 | Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsJOW · Traditional | 04/22/2009SE |
| K080424 | Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…NLF · Traditional | 05/28/2008SE |
| K053575 | Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsJOW · Traditional | 02/15/2006SE |
| K041867 | Hygia Health Services Reprocessed Oximax Sensors Model # Hhs-Max-A, Hhs-Max-Al, Hhs-Max-NNLF · Traditional | 09/10/2004SE |
| K032821 | Hygia Health Services Reprocessed Blood Pressure CuffNPP · Traditional | 12/05/2003SE |
| K021509 | Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089JOW · Abbreviated | 12/24/2002SE |
| K012657 | Hygia Health Services Reprocessed Nutech Calf WrapJOW · Traditional | 04/12/2002SE |
| K012654 | Hygia Health Services Reprocessed Huntleigh Flowtron DVT Sleeve Models DVT10, DVT 20…JOW · Traditional | 04/12/2002SE |
| K012651 | Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200JOW · Traditional | 04/12/2002SE |
Questions and answers
When was Hygia Health Services Reprocessed Nellcot D-25 Oxisensor II cleared by the FDA?
Hygia Health Services Reprocessed Nellcot D-25 Oxisensor II (K012715) received a 510(k) decision of Substantially Equivalent on August 1, 2003, 717 days after the submission was received.
What is the product code of K012715?
The FDA product code is NLF – Oximeter, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.2700.