510(k) · Cleared
ClearedCricket 2000 Recording Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · DQA Oximeter
Cleared on Oct 28, 1997 as substantially equivalent to K935510 (Vitalog Monitoring,Inc., 1994) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Oct 28, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K914085 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK914085 HMS-5000Vitalog Monitoring,Inc. · 1991
- This deviceK972829 Cricket 2000 Recording Pulse OximeterRespironics, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914085 | HMS-5000 | Vitalog Monitoring,Inc. | 1991 | — |
| 0 (this device) | K972829 | Cricket 2000 Recording Pulse Oximeter | Respironics, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K935510 | VX4 Recording Pulse OximeterSummary page 1…ent (supervised) and the home (unsupcrvised) environumnent. Predicate Devices: The predicate devices for the Cricket 2000 are the Vitalog VX4 Recording Pulse Oximeler (K935510) and the pulse oximetry component of the HIMS series (K914620/A and K914085). SERVICEy ta g, C DEPARTMENT OF HEA… | 1994 |
| * | K914620 | HMS-4000 Physiological Monitor, ModificationSummary page 1…redicate Devices: The predicate devices for the Cricket 2000 are the Vitalog VX4 Recording Pulse Oximeler (K935510) and the pulse oximetry component of the HIMS series (K914620/A and K914085). SERVICEy ta g, C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service EALTYH ot e K2 ‘%… | 1992 |
| * | K914085 | HMS-5000Summary page 1…es: The predicate devices for the Cricket 2000 are the Vitalog VX4 Recording Pulse Oximeler (K935510) and the pulse oximetry component of the HIMS series (K914620/A and K914085). SERVICEy ta g, C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service EALTYH ot e K2 ‘%," “Wvq1a Foo… | 1991 |
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.
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 Cricket 2000 is a recording pulse oximeter which measures functional blood oxygen saturation, pulse rate/interval and finger movement. Because of SpO2 and pulse rate alarm limits that can be set by the operator, it can be used for continuous monitoring. It also interfaces with a commercially available computer. The pulse oximetry, raw infrared and red waveform data, as well as the pulse rate data, can be viewed real-time on the computer using custom…
Read the full statement (153 words)
The Cricket 2000 is a recording pulse oximeter which measures functional blood oxygen saturation, pulse rate/interval and finger movement. Because of SpO2 and pulse rate alarm limits that can be set by the operator, it can be used for continuous monitoring. It also interfaces with a commercially available computer. The pulse oximetry, raw infrared and red waveform data, as well as the pulse rate data, can be viewed real-time on the computer using custom Windows®-based software that is provided with the pulse oximeter. The software also enables the user to do some data analysis, which can be used to draw meaningful implications during sleep apnea analysis studies. The Cricket 2000 is primarily indicated for use with patients suspected of suffering from, or with potential to suffer from, episodes of hypoxemia. The Cricket 2000 is intended for patients weighing more than 30 kg in both the hospital/institutional environment (supervised) and the home (unsupervised) environment.
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/K972829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972829: Cricket 2000 Recording Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972829
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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