510(k) Report

510(k) · Cleared

Cleared

Flexi-Site SP02 Ear Sensor

K012333510(k) SpecialCleared Oct 17, 200185-day reviewClass II21 CFR 870.2710

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Epic Medical Equipment Services, Inc. · DPZ Oximeter, Ear

Cleared on Oct 17, 2001 as substantially equivalent to K964055 (Epic Medical Equipment Services, Inc., 1997) and 2 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1985.

Decided
Oct 17, 2001
Review
85 days
Class
Class II
Product code
DPZ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K850494 (1985). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1997: 1 other ancestorReference device: K944760 · Dura-Y Oxygen Transducer, Ear Clip · Nellcor, Inc. · 1994K850494 · Ohmeda Biox 3700 Pulse Oximeter · Ohmeda Medical · 19851985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K850494 · Ohmeda Biox 3700 Pulse Oximeter · Ohmeda Medical · 19850
  1. Root · 1 generation backK850494 Ohmeda Biox 3700 Pulse OximeterOhmeda Medical · 1985
  2. This deviceK012333 Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K850494Ohmeda Biox 3700 Pulse OximeterOhmeda Medical1985—
0 (this device)K012333Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200110
FIG. 1 — Lineage of K012333, 1985–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DPZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K964055Flexi-Site (E203-01)/ Flexi-Fit (E300)
Summary page 1
…to ear oximeter) Trade Name(s): Flexi-Site SpO2 Ear Sensor Predicate Device: This product is substantially equivalent to the original Flexi-Site sensor, marketed under K964055, the Flexi-Site ear sensor marketed under K010718, and the Ohmeda 6051- 0000-115 sensor marketed under K850494. Accuracy is equiv…
Epic Medical Equipment Services, Inc.1997—
*K010718Flexi-Site SP02 Ear Sensor
Summary page 1
…r Sensor Predicate Device: This product is substantially equivalent to the original Flexi-Site sensor, marketed under K964055, the Flexi-Site ear sensor marketed under K010718, and the Ohmeda 6051- 0000-115 sensor marketed under K850494. Accuracy is equivalent to the Nellcor Dura- Y ear sensor, marketed…
Epic Medical Equipment Services, Inc.2001—
*K850494Ohmeda Biox 3700 Pulse Oximeter
Summary page 1
…uivalent to the original Flexi-Site sensor, marketed under K964055, the Flexi-Site ear sensor marketed under K010718, and the Ohmeda 6051- 0000-115 sensor marketed under K850494. Accuracy is equivalent to the Nellcor Dura- Y ear sensor, marketed under K944760. Description: The Flexi-Site SpO, Sensor is a…
Ohmeda Medical1985—
†K944760Dura-Y Oxygen Transducer, Ear ClipNellcor, Inc.1994—

Also cleared against K964055: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • 1 other device also cites its predicate K964055.

How does its category compare?

All DPZ devices

DPZ Oximeter, Ear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPZ

FDA has decided no DPZ device since 2007.

Median 510(k) review, days · DPZ

Too few DPZ 510(k)s in any year since 2007 to give a median.

Recalls per year · DPZ

1in 2011

2010: 12011: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DPZ

1in 2025

2009: 12010: 12011: 132012: 42013: 222014: 432015: 62016: 52017: 42018: 42019: 22021: 12022: 22024: 12025: 1
2007high 43 (2014) · low 0 (2007)2025

MAUDE reports naming product code DPZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—01
20100—11
20110—113
20120—04
20130—022
20140—043
20150—06
20160—05
20170—04
20180—04
20190—02
20200—00
20210—01
20220—02
20230—00
20240—01
20250—01
20260—0—

What is it indicated for?

The Flexi-Site SpO2 Ear Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing > 30 kg.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K964055

1 other device cites the same predicate.

  • K992211SPO2 Wrap SensorEpic Medical Equipment Services, Inc. · 1999

More from Epic Medical Equipment Services, Inc.

13 FDA decisions under this applicant name. See the company

  • K002848SPO2 Wrap SensorEpic Medical Equipment Services, Inc. · 2001
  • K010718Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc. · 2001
  • K002223Epic SPO2 Finger Sensor, Model E412-20Epic Medical Equipment Services, Inc. · 2000
  • K000831Stat-Shell Disposable SP02 SensorEpic Medical Equipment Services, Inc. · 2000
  • K992811Transducers for Ultrasound and Tocodynamometer Fetal MonitoringEpic Medical Equipment Services, Inc. · 2000

Recent decisions in DPZ

The DPZ category page

  • K042675Flexi-Stat SP02 Ear SensorElekon Industries U.S.A., Inc. · 2004
  • K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 20043 Class I recalls
  • K010718Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc. · 2001
  • K944760Dura-Y Oxygen Transducer, Ear ClipNellcor, Inc. · 1994
  • K942752Marquette Ear Probe SensorMarquette Electronics, Inc. · 1994

https://510kreport.com/device/K012333 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012333: Flexi-Site SP02 Ear Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012333

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026