510(k) Report

510(k) · Cleared

Cleared

Flexi-Site (E203-01)/ Flexi-Fit (E300)

K964055510(k) TraditionalCleared Feb 21, 1997135-day reviewClass II21 CFR 870.2700

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. · DQA Oximeter

Cleared on Feb 21, 1997 after a 135-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 21, 1997
Review
135 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared1999: 1 descendant cleared1995200020052010201520202025
  1. This deviceK964055 Flexi-Site (E203-01)/ Flexi-Fit (E300)Epic Medical Equipment Services, Inc. · 1997
  2. Descendant · cites it directly · 0 of its ownK012333 Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc. · 2001
  3. Descendant · cites it directly · 0 of its ownK992211 SPO2 Wrap SensorEpic Medical Equipment Services, Inc. · 1999

Most influential descendants

Showing 2 of 2 · See all
  • K012333Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc. · 2001 · cites it directly0descendants
  • K992211SPO2 Wrap SensorEpic Medical Equipment Services, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K964055Flexi-Site (E203-01)/ Flexi-Fit (E300)Epic Medical Equipment Services, Inc.1997—
+1K012333Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc.2001—
+1K992211SPO2 Wrap SensorEpic Medical Equipment Services, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
FIG. 1 — Lineage of K964055, 1997–2001Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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

Top candidate predicates for a new DQA device

  1. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012333Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc.20010
K992211SPO2 Wrap SensorEpic Medical Equipment Services, Inc.19990

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?

  • Of its descendants, K012333 (Epic Medical Equipment Services, Inc., 2001) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DQA devices

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

FDA decisions per year · DQA

15in 2025

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
2007high 32 (2018) · low 0 (2012)2026

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

Adverse event reports per year · DQA

399in 2025

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, 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
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

More from Epic Medical Equipment Services, Inc.

13 FDA decisions under this applicant name. See the company

  • K012333Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc. · 2001
  • 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

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https://510kreport.com/device/K964055 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964055: Flexi-Site (E203-01)/ Flexi-Fit (E300).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964055

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026