Atlas FDA

CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20

FDA 510(k) clearance K012622 · decided 2002-07-03

Clearance details

K-number
K012622
Device name
CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20
Applicant
Clearmedical, Inc.
Decision
Substantially Equivalent
Date received
2001-08-13
Decision date
2002-07-03
Days to decision
324 days
Clearance type
Traditional
Product code
NLF
Device class
2
Regulation number
870.2700
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Bellevue, WA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Clearmedical

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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) (K241758)Stryker Sustainability Solutions2024-10-22
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) (K222019)Stryker Sustainability Solutions2022-12-04
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) (K211138)Stryker Sustainability Solutions2022-03-08
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor (K201699)Surgical Instrument and Savings Inc (Dba Medline Renewal)2020-07-22
Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors (K191018)Surgical Instrument Service and Savings, Inc.2019-07-03
RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE (K111773)Renu Medical, Inc.2011-11-16
M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS (K110723)Masimo Corporation2011-07-28
REPROCESSED PULSE OXIMETER SENSORS (K102560)Sterilmed, Inc.2011-02-18
MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE (K101280)Midwest Reprocessing Center, LLC2010-10-07
REPROCESSED PULSE OXIMETER SENSORS (K092368)Sterilmed, Inc.2009-11-03
LNCS OXIMETRY SENSORS (K083719)Masimo Corporation2009-07-30
RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO (K081927)Renu Medical, Inc.2009-02-06

Recalls involving this device

No recalls on record reference this clearance.