Atlas FDA

Y-TYPE BLOOD SET

FDA 510(k) clearance K780880 · decided 1978-06-30

Clearance details

K-number
K780880
Device name
Y-TYPE BLOOD SET
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1978-05-30
Decision date
1978-06-30
Days to decision
31 days
Clearance type
Traditional
Product code
KDC
Device class
1
Regulation number
878.4800
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
DISPOSABLE SURGICAL SCISSORS AND FORCEPS (K943229)Y.M.K. International Co., Ltd.1994-08-19
SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET (K936226)Meadox Medicals, Div. Boston Scientific Corp.1994-03-07
THERMUFF BAG (K920153)Techstyles1992-07-01
MANUAL SURGICAL INSTRUMENTS (K920263)Phoenix Instruments Div.1992-05-06
DISPOSABLE CAUTERY ABRASIVE PAD (K915064)American Medical Mfg., Inc.1992-03-11
INSTRUMENT ORGANIZER (K914960)O.R. Concepts, Inc.1992-02-28
SHUR-GRIP (K912834)Inman Medical Corp.1991-07-26
DISPOSABLE INTRODUCER SHEATH (K910079)Applied Vascular Devices, Inc.1991-02-27
VESSELOOPS (K905240)Sparta Surgical Corp.1991-02-06
BRADLEY TENACULUM HOLDER (K903649)Marlo Surgical Technology1990-11-02
RICHARD-ALLAN VESSEL LOOPS (K900566)Richard-Allan Medical Ind., Inc.1990-05-03
KEY VASCULAR LOOPS (K896676)Key Surgical, Inc.1990-02-27

Recalls involving this device

RecordFirmDate
Hospira Latex-Free Blood Secondary Set, 26 Inch with Secure Lock; a sterile Rx tubing set recall (Z-2024-2011)Hospira Inc.2011-04-19
Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 100 Inch with Clave and Se recall (Z-2025-2011)Hospira Inc.2011-04-19
Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 99 Inch with Drip Chamber recall (Z-2026-2011)Hospira Inc.2011-04-19
Lifeshield, latex-free, Y-Type Blood Set, nonvented, 100 inch with CLAVE and secure lock, recall (Z-1392-2010)Hospira Inc.2010-04-15

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30