Atlas FDA

FLO-GARD(R) 6201

FDA 510(k) clearance K915522 · decided 1992-02-28

Clearance details

K-number
K915522
Device name
FLO-GARD(R) 6201
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1991-12-10
Decision date
1992-02-28
Days to decision
80 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Round Lake, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Baxter Healthcare Corp

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
RemunityPRO+ Pump for Remodulin® (treprostinil) Injection (K253703)Deka R&D Corp2026-07-24
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing (K252015)Koru Medical Systems, Inc.2026-01-28
SIGMA Spectrum Infusion Pump with Master Drug Library (K251640)Baxter Healthcare Corporation2025-07-28
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (K251636)Baxter Healthcare Corporation2025-07-28
MRidium 3870 MRI Infusion Pump System (3870) (K242752)Iradimed Corporation2025-05-28
BD Alaris Infusion System with Guardrails Suite MX (K243855)Carefusion 303, Inc.2025-04-25
Plum Solo™ Precision IV Pump (K242114)Icu Medical, Inc.2025-04-02
Plum Duo™ Precision IV Pump (K242115)Icu Medical, Inc.2025-04-02
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (K250357)Deka Research & Development Corp.2025-03-11
Remunity 2.0 Pump for Remodulin (treprostinil) Injection (K241736)Deka Research and Development Corp.2025-01-16
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) (K242735)Belmont Medical Technologies2024-12-23
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets (K242660)Zevex, Inc.2024-10-03

Recalls involving this device

RecordFirmDate
Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporati recall (Z-2122-2011)Baxter Healthcare Corp.2011-04-29
Baxter FloGard 6201 Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication De recall (Z-0933-2011)Baxter Healthcare Corp.2011-01-21
Baxter Flo-Gard 6201, SIngle Channel , Volumetric Infusion Pump; Baxter Healthcare Corpora recall (Z-1111-2007)Baxter Healthcare Corp.2007-07-28
Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished); Bax recall (Z-0632-2007)Baxter Healthcare Corp.2007-03-20
Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished), 2M8 recall (Z-1552-05)Baxter Healthcare Corp.2005-09-21
Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refu recall (Z-1553-05)Baxter Healthcare Corp.2005-09-21

PMA approvals by this applicant

RecordFirmDate
Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077)Baxter Healthcare Corp2025-11-13
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076)Baxter Healthcare Corp2025-06-30
Floseal Hemostatic Matrix (P990009/S075)Baxter Healthcare Corp2025-01-30
Adept Adhesion Reduction Solution (P050011/S009)Baxter Healthcare Corp2024-08-23
Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074)Baxter Healthcare Corp2024-08-15
Floseal Hemostatic Matrix (P990009/S073)Baxter Healthcare Corp2024-01-10
Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072)Baxter Healthcare Corp2023-12-12
Floseal Hemostatic Matrix, RT5 (P990009/S070)Baxter Healthcare Corp2023-02-02