510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K052828Substantially Equivalent

Disposable Transpac III Integrated Transducer (It)

Abbott Medical, Lake Forest IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052828 is the FDA 510(k) clearance record for DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT), a class II device, cleared for Hospira, Inc. on under FDA product code DRS (Transducer, Blood-Pressure, Extravascular). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show one recall naming K052828.

Clearance record

Decision date
Received
(135 days to decision)
Product code
DRS Transducer, Blood-Pressure, Extravascular
Regulation
21 CFR 870.2850
Device class
Class II
Review panel
Cardiovascular
Applicant
Hospira, Inc. 275 N. Field Dr., Lake Forest IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRS

Trailing 12 months
1 clearance under product code DRS in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260