DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)— 510(k) K052828

Name: FDA 510(k) clearance K052828
Creator: U.S. Food and Drug Administration
Published: 2006-02-17

Substantially Equivalent

Hospira, Inc.

FDA 510(k) clearance K052828 for DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT), Substantially Equivalent on 2006-02-17. Applicant: Hospira, Inc.. Device class: 2.

Clearance details

Applicant: Hospira, Inc.
Product code: Code DRS
Device class: Class 2
Regulation: 21 CFR 870.2850
Advisory panel: Cardiovascular
Date received: 2005-10-05
Decision date: 2006-02-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Lake Forest, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRS

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More clearances from Hospira, Inc.

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K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module2017-03-28
K161036 — Hospira Extension Set, Hospira Primary Set2017-01-06
K160492 — Hospira Sapphire Sets2016-12-06
K160870 — Hospira Administration Sets2016-06-01
K143612 — LifeCare PCA Infusion System2016-04-08

Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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 →

Recalls naming K052828

K-number listed on FDA's recall record

Z-1071-2019 — ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EOClass II·Terminated·ICU Medical, Inc.·20181127

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052828.

Data sourced from openFDA. This site is unofficial and independent of the FDA.