510(k) · Cleared
ClearedHP Orvue Intra-OP (M2510A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard GmbH · BSZ Gas-Machine, Anesthesia
Cleared on Sep 11, 1997 as substantially equivalent to K922210 (Hewlett-Packard Co., 1993) and 2 other predicates after a 262-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Sep 11, 1997
- Review
- 262 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K870380 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK870380 Model 78534C Monitor/Terminal W/Options A03Hewlett-Packard Co. · 1987
- This deviceK965160 HP Orvue Intra-OP (M2510A)Hewlett-Packard GmbH · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870380 | Model 78534C Monitor/Terminal W/Options A03 | Hewlett-Packard Co. | 1987 | — |
| 0 (this device) | K965160 | HP Orvue Intra-OP (M2510A) | Hewlett-Packard GmbH | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 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 BSZ? 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 BSZ device
- #1 K253330 A5 Anesthesia System (A5); A7 Anesthesia…score 16.7 · 18 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 |
|---|---|---|---|
| * | K922210 | Hewlett-Packard Model 78730 Carevue 5000Summary page 1…coupled with Recording of the above described Calculations, this device is similar to the previously submitted CareVue 5000 system cleared to market under 510(k) number K922210 while the Calculations are identical to those of the market cleared devices Component Monitoring System Model HP M1175/76A [K9220… | 1993 |
| * | K922058 | Models M1175A and M1176A Component Monitoring SystSummary page 1…cleared to market under 510(k) number K922210 while the Calculations are identical to those of the market cleared devices Component Monitoring System Model HP M1175/76A [K922058] and Patient Monitor Model HP 78534C [K870380]. ' # Description Validation The HP ORVue Intra-Op [M2510A] Intr… | 1992 |
| * | K870380 | Model 78534C Monitor/Terminal W/Options A03Summary page 1…while the Calculations are identical to those of the market cleared devices Component Monitoring System Model HP M1175/76A [K922058] and Patient Monitor Model HP 78534C [K870380]. ' # Description Validation The HP ORVue Intra-Op [M2510A] Intraoperative Recording System is a product that… | 1987 |
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 K922210.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSZ
145in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSZ
5in 2025
Class I (38 since 2007) Class II/III not classified
Adverse event reports per year · BSZ
9,198in 2025
MAUDE reports naming product code BSZ, 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 | 3 | 175 | 1 | 132 |
| 2008 | 8 | 99 | 8 | 104 |
| 2009 | 3 | 34 | 3 | 85 |
| 2010 | 1 | — | 14 | 97 |
| 2011 | 6 | 218 | 1 | 87 |
| 2012 | 5 | 134 | 7 (6) | 89 |
| 2013 | 5 | 125 | 5 (5) | 308 |
| 2014 | 4 | 235 | 0 | 279 |
| 2015 | 4 | 134 | 7 (2) | 572 |
| 2016 | 1 | — | 1 | 2,135 |
| 2017 | 3 | 145 | 5 (1) | 2,355 |
| 2018 | 2 | — | 3 | 2,589 |
| 2019 | 0 | — | 5 (2) | 1,957 |
| 2020 | 1 | — | 7 | 2,687 |
| 2021 | 1 | — | 2 (1) | 3,123 |
| 2022 | 0 | — | 4 (3) | 4,352 |
| 2023 | 2 | — | 6 | 5,595 |
| 2024 | 0 | — | 13 (13) | 6,067 |
| 2025 | 1 | — | 5 (3) | 9,198 |
| 2026 | 2 | — | 7 (2) | — |
What is it indicated for?
The HP ORVue Intra-Op [M2510A] Intraoperative Recording System is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for a anesthesia record. This product is indicated for all patients requiring a anesthesia record. The specific medical indication for use of this device is: « This device is a prescription device. o This device is not intended to contact the patient. e This device is used continuously in…
Read the full statement (129 words)
The HP ORVue Intra-Op [M2510A] Intraoperative Recording System is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for a anesthesia record. This product is indicated for all patients requiring a anesthesia record. The specific medical indication for use of this device is:
« This device is a prescription device.
o This device is not intended to contact the patient.
e This device is used continuously in Operating Theatres during Anesthesia
« The Recording of calculations (Fluid, Hemodynamic, Renal, Oxygenation and Ventilation) indicated for any patient who will have medication administered and which requires dose computation.
« The physiological purpose is indirect. The device is intended to gather and store patient information during Anesthesia, and to document computed calculations as needed by care providers.
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/K965160 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965160: HP Orvue Intra-OP (M2510A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965160
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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