510(k) · Cleared
ClearedCompurecord Peri-Operative Anesthesiology Information System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · BSZ Gas-Machine, Anesthesia
Cleared on Dec 18, 2008 as substantially equivalent to K030939 (Philips Medical Systems, 2003) after a 30-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Dec 18, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K854213 (1985). No later device cites it as a predicate yet.
- Root · 2 generations backK854213 Ari Standard Anesthesia RecordAgilent Technologies, Inc. · 1985
- 1 generation backK030939 Philips Compurecord Peri-Operative Information System SoftwarePhilips Medical Systems · 2003
- This deviceK083413 Compurecord Peri-Operative Anesthesiology Information SystemPhilips Medical Systems · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854213 | Ari Standard Anesthesia Record | Agilent Technologies, Inc. | 1985 | — |
| −1 | K030939 | Philips Compurecord Peri-Operative Information System Software | Philips Medical Systems | 2003 | — |
| 0 (this device) | K083413 | Compurecord Peri-Operative Anesthesiology Information System | Philips Medical Systems | 2008 | — |
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? (1)
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 |
|---|---|---|---|
| * | K030939 | Philips Compurecord Peri-Operative Information System SoftwareSummary page 1…Machine, Anesthesia I. The new device is substantially equivalent to the previously cleared Philips CompuRecord Software, Release D.0 marketed pursuant to K030939. 2. The modifications made to CompuRecord include the following enhancements plus non-safety related bug fixes: Im… | 2003 |
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?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 17.6 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K030939.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Philips CompuRecord Peri-Operative Anesthesia Information System Software is a computer-based system which collects, processes, and records data directly from medical monitors which themselves are attached to the patients in the operating room environment.
CompuRecord is generally indicated in the peri-operative environment when the anesthetist decides to generate a paper and electronic version of the administration of anesthesia to a patient, perform a pre-operative assessment, and document (chart) nursing care in the PACU.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083413 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083413: Compurecord Peri-Operative Anesthesiology Information System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083413
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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