Atlas FDA

FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT

FDA 510(k) clearance K915735 · decided 1992-06-24

Clearance details

K-number
K915735
Device name
FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1991-12-20
Decision date
1992-06-24
Days to decision
187 days
Clearance type
Traditional
Product code
KNT
Device class
2
Regulation number
876.5980
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Columbus, OH, US
Third-party review
No
Expedited review
No

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

RecordFirmDate
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) (K253514)C.R. Bard, Inc.2026-07-10
XNY Disposable Gastric Calibration Tube (K250389)Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd2025-04-10
Flexi-Seal AIR (with ENFit Connector) (K243228)Convatec2025-03-28
hygh-tec Drainage II (K242336)Amb Medtec2025-01-17
ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) (K242901)Tools For Surgery, LLC2025-01-10
Entarik NI Feeding Tube System (K241169)Gravitas Medical, Inc.2024-11-22
CORGRIP* SR NG/NI Tube Retention System (K241185)Avanos Medical, Inc.2024-10-25
CORTRAK* 2 Enteral Access System (20-0950) (K240965)Avanos Medical, Inc.2024-06-06
Stylus (K233591)Degania Silicone , Ltd.2024-05-31
ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) (K241039)Reshape Lifesciences2024-05-16
ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (K234033)Boehringer Laboratories, LLC2024-05-06
Enteral Feeding Sets (K240039)Hangzhou Primecare Medical Co., Ltd.2024-04-17

Recalls involving this device

RecordFirmDate
Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum recall (Z-2305-2008)Abbott Laboratories2008-09-20

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