510(k) · Cleared
ClearedPhilips Compurecord Peri-Operative Information System Software
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 Jul 15, 2003 as substantially equivalent to K854213 (Agilent Technologies, Inc., 1985) after a 112-day review. Its family tree reaches back 1 generation to 1985. 8 later devices descend from it.
- Decided
- Jul 15, 2003
- Review
- 112 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854213 (1985). 8 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK854213 Ari Standard Anesthesia RecordAgilent Technologies, Inc. · 1985
- This deviceK030939 Philips Compurecord Peri-Operative Information System SoftwarePhilips Medical Systems · 2003
- Descendant · cites it directly · 6 of its ownK050883 Safersleep SystemSafer Sleep, LLC · 2005
- Descendant · cites it directly · 5 of its ownK062388 Anesthesia Information and Digital-Drug Management SystemDocusys · 2007
- Descendant · 2 generations on · 2 of its ownK141474 Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK182092 BD Intelliport SystemBecton, Dickinson and Company · 2019
- Descendant · cites it directly · 1 of its ownK101439 Codonics Safe Labeling System (SLS), Model 500I/500PCodonics, Inc. · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K050883Safersleep SystemSafer Sleep, LLC · 2005 · cites it directly6descendants
- K062388Anesthesia Information and Digital-Drug Management SystemDocusys · 2007 · cites it directly5descendants
- K141474Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 2014 · 2 generations on2descendants
- K182092BD Intelliport SystemBecton, Dickinson and Company · 2019 · 3 generations on1descendant
- K101439Codonics Safe Labeling System (SLS), Model 500I/500PCodonics, Inc. · 2011 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854213 | Ari Standard Anesthesia Record | Agilent Technologies, Inc. | 1985 | — |
| 0 (this device) | K030939 | Philips Compurecord Peri-Operative Information System Software | Philips Medical Systems | 2003 | — |
| +1 | K050883 | Safersleep System | Safer Sleep, LLC | 2005 | — |
| +1 | K062388 | Anesthesia Information and Digital-Drug Management System | Docusys | 2007 | — |
| +2 | K141474 | Becton Dickinson Intelliport System | Becton, Dickinson & CO | 2014 | 1 |
| +3 | K182092 | BD Intelliport System | Becton, Dickinson and Company | 2019 | — |
| +1 | K101439 | Codonics Safe Labeling System (SLS), Model 500I/500P | Codonics, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K854213 | Ari Standard Anesthesia RecordSummary page 1…sia 868.1890 Calculator, Drug Dose 3. The new device is substantially equivalent to the previously cleared Philips device marketed pursuant to K854213. 4. The modification is primarily a software based change that updates the operating system and allows network use and web ac… | 1985 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K050883 (Safer Sleep, LLC, 2005) has gone furthest, with 6 descendants of its own.
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 Philips CompuRecord Peri-Operative Anesthesiology Information System Software is a computer-based system which collects, processes, and records data directly from anesthesiological monitors which themselves are attached to 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 record of the administration of anesthesia to a patient, perform a pre-operative assessment, and documentation of [chart] nursing care in the PACU.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030939: Philips Compurecord Peri-Operative Information System Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030939
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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