# K062388: Anesthesia Information and Digital-Drug Management System

- Pathway: 510(k) (Traditional)
- Applicant: Docusys
- Decided: Feb 22, 2007 after 191 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904518 (1990). 9 ancestors in all.
5 later devices descend from it; 2 cite it directly.
3 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030939: Philips Compurecord Peri-Operative Information System Software, Philips Medical Systems (2003) Summary page 1.
- K050883: Safersleep System, Safer Sleep, LLC (2005) Summary page 1.

## Most influential descendants
- K141474: Becton Dickinson Intelliport System (2014), 2 descendants of its own
- K182092: BD Intelliport System (2019), 1 descendant of its own
- K101439: Codonics Safe Labeling System (SLS), Model 500I/500P (2011), 1 descendant of its own
- K251352: Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) (2025), 0 descendants of its own
- K243062: BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K062388
Methodology: https://510kreport.com/methodology