510(k) · Cleared
ClearedIndex 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Tek Instruments, Inc. · DQA Oximeter
Cleared on Oct 8, 1997 as substantially equivalent to K933519 (Bio-Tek Instruments, Inc., 1994) and 1 other predicate after a 184-day review. Its family tree reaches back 1 generation to 1994. 22 later devices descend from it.
- Decided
- Oct 8, 1997
- Review
- 184 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933519 (1994). 2 ancestors in all. 22 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK933519 Index SPO2 SimulatorBio-Tek Instruments, Inc. · 1994
- This deviceK971273 Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F…Bio-Tek Instruments, Inc. · 1997
- Descendant · cites it directly · 21 of its ownK992340 Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop…Masimo Corp. · 1999 · Recalled
- Descendant · 2 generations on · 11 of its ownK062144 Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation · 2006
- Descendant · 3 generations on · 10 of its ownK090556 Spacelabs Elance Vital Signs Monitoring System and Central Monitor…Spacelabs Healthcare Medical Equipment (Suzhou) CO · 2009 · Recalled
- Descendant · 2 generations on · 5 of its ownK040178 Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd. · 2004
- Descendant · 4 generations on · 3 of its ownK130740 Nightingale Monitoring SystemZoe Medical, Inc. · 2013
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K992340Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999 · cites it directly21descendants
- K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation · 2006 · 2 generations on11descendants
- K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO · 2009 · 3 generations on10descendants
- K040178Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd. · 2004 · 2 generations on5descendants
- K130740Nightingale Monitoring SystemZoe Medical, Inc. · 2013 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933519 | Index SPO2 Simulator | Bio-Tek Instruments, Inc. | 1994 | — |
| 0 (this device) | K971273 | Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EF | Bio-Tek Instruments, Inc. | 1997 | — |
| +1 | K992340 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop… | Masimo Corp. | 1999 | 1 |
| +2 | K062144 | Escort M8 Vital Signs Patient Monitor, Model 3810 | Invivo Corporation | 2006 | — |
| +3 | K090556 | Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software | Spacelabs Healthcare Medical Equipment (Suzhou) CO | 2009 | 1 |
| +2 | K040178 | Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device | S.P.O. Medical Equipment, Ltd. | 2004 | — |
| +4 | K130740 | Nightingale Monitoring System | Zoe Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
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 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 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K933519 | Index SPO2 SimulatorSummary page 1…F & CardioSat 100 E, F, EF 4- Substantially Equivalent to: The device family is equivalent to the legally marketed ‘ predicate devices: Bio-Tek Instruments, Inc. Index, K933519, SpO, Simulator which has ! many of the same features for total oximeter testing; and to the Clinical Dynamics Corp. SmartSat™ Pu… | 1994 |
| * | K952327 | Smartsat Pulse Oximetry AnalyzerSummary page 1…c. Index, K933519, SpO, Simulator which has ! many of the same features for total oximeter testing; and to the Clinical Dynamics Corp. SmartSat™ Pulse Oximetry Analyzer, K952327 primarily in the area of electrical simulation of the pulse oximeter and the testing of oximeter probes. | Index 2 and CardioSat… | 1995 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992340 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric… | 1999 | 21 |
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?
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The above device family is intended for use as simulators, testers/analyzers for Pulse Oximeters, and their probes. The Oximeter tests can be conducted through a simulated human “finger” (F and EF models) or electronically (E and EF models) as if the tester is a probe. Oximeter probes can be tested, using E and EF models, for shorts, continuity, opens and LED functionality. Basically the devices allow accurate monitoring and verification of the operation…
Read the full statement (296 words)
The above device family is intended for use as simulators, testers/analyzers for Pulse Oximeters, and their probes. The Oximeter tests can be conducted through a simulated human “finger” (F and EF models) or electronically (E and EF models) as if the tester is a probe. Oximeter probes can be tested, using E and EF models, for shorts, continuity, opens and LED functionality.
Basically the devices allow accurate monitoring and verification of the operation of commercially available Pulse Oximeters without use of arterial blood. They can quickly establish the state of any given pulse oximeter and determine its performance qualities.
Index 2/CardioSat 100 can test and evaluate virtually any pulse oximeter on the market today. Ear and toe type oximeters and their probes can be tested electronically as components and the probe/oximeter system can be tested fully if the probe fits on the simulated “finger”.
The testers can also be used as a transfer standard for Pulse Oximeters. That is, a Pulse Oximeter’s performance may be compared to another of the same type or a different type.
The devices are not intended to be used as Pulse Oximeter calibrators, but can be used for Quality Control purposes.
The primarily use for these types of devices is: by Biomedical Engineers and technicians in Hospitals; by third party repair and calibration facilities; and by Original Equipment Manufacturers (OEMs). Other personnel could also learn how to use the devices. The Hospital or third party repair environment varies from, use of the device in a controlled calibration lab, to portable ward use by the Biomed staff. The OEMs use of the device would primarily involve final QC of pulse oximeters in their manufacturing or repair facilities, but could also involve the use of these simulators in the development of new oximeters.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971273 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971273: Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971273
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026