510(k) · Cleared
ClearedAnesthesia Information and Digital-Drug Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Docusys · BSZ Gas-Machine, Anesthesia
Cleared on Feb 22, 2007 as substantially equivalent to K030939 (Philips Medical Systems, 2003) and 1 other predicate after a 191-day review. Its family tree reaches back 5 generations to 1990. 3 of the 15 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Feb 22, 2007
- Review
- 191 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K904518 (1990). 9 ancestors in all, the oldest K854213 (1985). 5 later devices descend from it, 2 citing it directly. 3 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 4 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 3 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 2 generations backK041241 Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · Recalled (Class I)
- 1 generation backK050883 Safersleep SystemSafer Sleep, LLC · 2005
- This deviceK062388 Anesthesia Information and Digital-Drug Management SystemDocusys · 2007
- Descendant · cites it directly · 2 of its ownK141474 Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 2014 · Recalled
- Descendant · 2 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
- Descendant · 2 generations on · 0 of its ownK251352 Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i…Codonics.Incorporated · 2025
- Descendant · 3 generations on · 0 of its ownK243062 BD Intelliport System; BD Intelliport Reader (516230); BD…Becton Dickinson · 2025
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K141474Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 2014 · cites it directly2descendants
- K182092BD Intelliport SystemBecton, Dickinson and Company · 2019 · 2 generations on1descendant
- K101439Codonics Safe Labeling System (SLS), Model 500I/500PCodonics, Inc. · 2011 · cites it directly1descendant
- K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i…Codonics.Incorporated · 2025 · 2 generations on0descendants
- K243062BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229)…Becton Dickinson · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −4 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −3 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −2 | K041241 | Medley System with Bar Code Module, Model 8600 | Alaris Medical Systems, Inc. | 2004 | Class I |
| −1 | K050883 | Safersleep System | Safer Sleep, LLC | 2005 | — |
| 0 (this device) | K062388 | Anesthesia Information and Digital-Drug Management System | Docusys | 2007 | — |
| +1 | K141474 | Becton Dickinson Intelliport System | Becton, Dickinson & CO | 2014 | 1 |
| +2 | K182092 | BD Intelliport System | Becton, Dickinson and Company | 2019 | — |
| +1 | K101439 | Codonics Safe Labeling System (SLS), Model 500I/500P | Codonics, Inc. | 2011 | — |
| +2 | K251352 | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and… | Codonics.Incorporated | 2025 | — |
| +3 | K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor… | Becton Dickinson | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1994 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
3 devices in this family have a Class I recall. 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? (2)
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…5160 Class 1I Anesthesiology Panel Predicate Devices 1) PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM (K030939) 2) SAFERsleep System (K050883) INTENDED USE The DocuSys Anesthesia Information and digital-Drug Ma… | 2003 |
| * | K050883 | Safersleep SystemSummary page 1…iology Panel Predicate Devices 1) PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM (K030939) 2) SAFERsleep System (K050883) INTENDED USE The DocuSys Anesthesia Information and digital-Drug Management System offers anesthesia a comprehens… | 2005 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K041241Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 9 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K141474 (Becton, Dickinson & CO, 2014) has gone furthest, with 2 descendants of its own.
- 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. 2007, 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 DocuSys Anesthesia information and digital-Drug Management System offers anesthesia a comprehensive record keeping system with advanced patient safety features. The clinician begins interacting with the system through the electronic anesthesia pre-operative assessment in which patient data relative to anesthesia is recorded. Electronic documentation of the patient's allergies and home medications allows for proactive adverse drug event screening when…
Read the full statement (260 words)
The DocuSys Anesthesia information and digital-Drug Management System offers anesthesia a comprehensive record keeping system with advanced patient safety features. The clinician begins interacting with the system through the electronic anesthesia pre-operative assessment in which patient data relative to anesthesia is recorded. Electronic documentation of the patient's allergies and home medications allows for proactive adverse drug event screening when the patient is in the operating room prior to anesthesia delivering drugs.
The DocuSafe electronic anesthesia information system allows the clinician to record anesthesia related events in the pre-op, intra-op, and PACU areas. The DocuSafe software receives physiologic data from various patient monitoring devices. Clinicians enter drug information onto the anesthesia record in one of two methods: a) manually selecting the drug from a list of drugs in the formulary, or b) through the use of DocuSys' optional digital-Drug Management System. If the optional d-DMS is used, the clinician may scan a barcode affixed to a Syringe Label Cradle or use DocuJect to record the drug delivery. A Formulary Reference module, managed by pharmacy, contains drug specific information used for documenting drugs on the anesthesia record, performing ADE checks, and submitting medication utilization information for billing purposes.
The DocuRx pharmacy component of the digital-Drug Management System provides for pre-screening of medications that are ordered by anesthesia to check for any potential adverse drug events. It also provides a methodology for narcotics tracking through its comprehensive medication tracking and wasting feature.
Each component of the Anesthesia Information and digital-Drug Management System plays an integral part in standardizing medication administration techniques and documentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062388: Anesthesia Information and Digital-Drug Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062388
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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