510(k) · Cleared
Recalled · 2004Corometrics Model 510 and 511 Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · BZQ Monitor, Breathing Frequency
Cleared on Mar 6, 1997 as substantially equivalent to K943308 (Ge Medical Systems Information Technologies, 1995) and 4 other predicates after a 232-day review. Its family tree reaches back 1 generation to 1987. It has been recalled once.
- Decided
- Mar 6, 1997
- Review
- 232 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 1 generation to K871302 (1987). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK871302 Model 2000W Option H ConfigurationEdentec Corp. · 1987
- This deviceK962781 Corometrics Model 510 and 511 MonitorGe Medical Systems Information Technologies · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871302 | Model 2000W Option H Configuration | Edentec Corp. | 1987 | — |
| 0 (this device) | K962781 | Corometrics Model 510 and 511 Monitor | Ge Medical Systems Information Technologies | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1995 | 2 | 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 BZQ? 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 BZQ device
- #1 K251326 Respiration Rate algorithmscore 20.2 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K943308 | Model 510 Infant MonitorSummary page 1…itor; 870.2300, cardiac monitor; and 870.2700, oximeter. [21 CFR § 807.92(a)3] Ildentification of Legally Marketed Devices Model 510 Corometrics Medical Systems, Inc. (k943308, 7/25/95) Model 511 Corometrics Medical Systems, Inc. (k942179, 6/2/95) EdenTec Model 2000W EdenTec Option H (K871302, 4/20/87… | 1995 |
| * | K942170 | Model 511 Infant Monitor Our OCR of the scanned summary read K942179, FDA’s number for Pro-Tec Disposable Sharps Containers (Pro-Tec Containers, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Model 511”. | 1995 |
| * | K871302 | Model 2000W Option H ConfigurationSummary page 1…es Model 510 Corometrics Medical Systems, Inc. (k943308, 7/25/95) Model 511 Corometrics Medical Systems, Inc. (k942179, 6/2/95) EdenTec Model 2000W EdenTec Option H (K871302, 4/20/87 and k905575, 6/20/91) Nellcor N-180 Pulse Oximeter | Nellcor Puritan Bennett (k913695, 11/13/95) *SE - Substantial Equ… | 1987 |
| * | K905575 | Modified Models 2000W and 2000W Option H Apnea MonSummary page 1…rics Medical Systems, Inc. (k943308, 7/25/95) Model 511 Corometrics Medical Systems, Inc. (k942179, 6/2/95) EdenTec Model 2000W EdenTec Option H (K871302, 4/20/87 and k905575, 6/20/91) Nellcor N-180 Pulse Oximeter | Nellcor Puritan Bennett (k913695, 11/13/95) *SE - Substantial Equivalence [21 CFR § 8… | 1991 |
| * | K913695 | Nellcor (R) N-180 Pulse OximeterSummary page 1…l Systems, Inc. (k942179, 6/2/95) EdenTec Model 2000W EdenTec Option H (K871302, 4/20/87 and k905575, 6/20/91) Nellcor N-180 Pulse Oximeter | Nellcor Puritan Bennett (k913695, 11/13/95) *SE - Substantial Equivalence [21 CFR § 807.92(a)4,5] Device Description & Intended Use The Model 510 Series consis… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2004 | Not classified | Z-1023-04 | Other | Device may not alarm for %SpO2 value limit violations if a specific feature is enabled |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 5 ancestors has a recall.
How does its category compare?
All BZQ devicesBZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZQ
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZQ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZQ
2in 2022
MAUDE reports naming product code BZQ, 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 | 2 | — | 0 | 7 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 121 | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 3 | 261 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 3 | 198 | 0 | 10 |
| 2019 | 1 | — | 0 | 13 |
| 2020 | 2 | — | 0 | 10 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 198 | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 7 | 255 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
These monitors were originally cleared for monitoring respiration, heart rate, optional pulse oximetry and for detecting central apnea in infants in the home and hospital environments.
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/K962781 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962781: Corometrics Model 510 and 511 Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962781
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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