MCKESSON ANESTHESIA CARE— 510(k) K113633

Clearance details

Applicant

Mckesson Technologies, Inc.

Product code

Code BSZ

Device class

Class 2

Regulation

21 CFR 868.5160

Advisory panel

Anesthesiology

Date received

2011-12-08

Decision date

2012-04-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Philedelphia, PA, US

• K253330 — A5 Anesthesia System (A5); A7 Anesthesia System (A7)2026-06-25
• K252746 — Atlan (4 models)2026-05-21
• K251352 — Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features) +1 more2025-07-11
• K230931 — Atlan2023-07-23
• K213867 — Carestation 750/750c2023-03-28

Death

23

Injury

298

Malfunction

32,987

Total

33,308

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1060-2014 — McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.Class I·Terminated·MCKESSON TECHNOLOGIES INC.·20130315

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113633.