510(k) Report

510(k) · Cleared

Cleared

Fluidsense Fluid Delivery System

K982170510(k) TraditionalCleared Nov 30, 1998164-day reviewClass II21 CFR 880.5725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fluidsense Corp. · FRN Pump, Infusion

Cleared on Nov 30, 1998 as substantially equivalent to K870991 (Imed Corp., 1987) and 2 other predicates after a 164-day review. Its family tree reaches back 2 generations to 1992.

Decided
Nov 30, 1998
Review
164 days
Class
Class II
Product code
FRN
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K915571 (1992). 4 ancestors in all, the oldest K870991 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1991: 1 other ancestor1987: 1 other ancestorK915571 · Clave Connector · Icu Medical, Inc. · 1992 · recalledK960661 · Maxcess Needle Free Connector (8200) · Solopak Medical Products, Inc. · 19961985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K960661 · Maxcess Needle Free Connector (8200) · Solopak Medical Products, Inc. · 1996K915571 · Clave Connector · Icu Medical, Inc. · 1992 · recalled0
  1. Root · 2 generations backK915571 Clave ConnectorIcu Medical, Inc. · 1992 · Recalled
  2. 1 generation backK960661 Maxcess Needle Free Connector (8200)Solopak Medical Products, Inc. · 1996
  3. This deviceK982170 Fluidsense Fluid Delivery SystemFluidsense Corp. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K915571Clave ConnectorIcu Medical, Inc.19923
−1K960661Maxcess Needle Free Connector (8200)Solopak Medical Products, Inc.1996—
0 (this device)K982170Fluidsense Fluid Delivery SystemFluidsense Corp.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199110
FIG. 1 — Lineage of K982170, 1992–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FRN device

  1. #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K870991Imed (R) Model 960A Volumetric Infusion Pump
Summary page 1
…y and performance to those included on prior legally marketed infusion pumps and accessory IV sets. The FluidSense Fluid Delivery System is Substantially Equivalent to: K870991, Model 960A Volumetric Infusion Pump, Manufactured by IMED Corporation K912928, Lifecare 4100 PCA Infuser Plus II, Manufactured b…
Imed Corp.1987—
*K912928Lifecare 4100 Pca Infuser Plus II
Summary page 1
…d accessory IV sets. The FluidSense Fluid Delivery System is Substantially Equivalent to: K870991, Model 960A Volumetric Infusion Pump, Manufactured by IMED Corporation K912928, Lifecare 4100 PCA Infuser Plus II, Manufactured by Abbott Laboratories K960661, Maxcess Needle Free Connector (8200), Manufactur…
Abbott Laboratories19912
*K960661Maxcess Needle Free Connector (8200)
Summary page 1
…alent to: K870991, Model 960A Volumetric Infusion Pump, Manufactured by IMED Corporation K912928, Lifecare 4100 PCA Infuser Plus II, Manufactured by Abbott Laboratories K960661, Maxcess Needle Free Connector (8200), Manufactured by Solopak Medical Products Device Description and Intended Use: The FluidS…
Solopak Medical Products, Inc.1996—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
  • 2 of the 4 ancestors have a recall of any class.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRN

8in 2025

2007: 122008: 82009: 92010: 32011: 32012: 42013: 62014: 62015: 32016: 32017: 32018: 32019: 22020: 12021: 22022: 62023: 72024: 52025: 82026 (partial year): 2
2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007: 102 days median2008: 89 days median2009: 66 days median2010: 93 days median2011: 103 days median2012: 217 days median2013: 312 days median2014: 172 days median2015: 232 days median2016: 301 days median2017: 305 days median2018: 267 days median2022: 268 days median2023: 265 days median2024: 103 days median2025: 172 days median
2007high 312 (2013) · low 66 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRN

7in 2025

2007: 152008: 242009: 1022010: 372011: 692012: 42, 2 Class I2013: 22, 3 Class I2014: 4, 3 Class I2015: 52016: 7, 1 Class I2017: 132018: 12019: 18, 1 Class I2020: 16, 5 Class I2021: 3, 2 Class I2022: 22023: 16, 10 Class I2024: 9, 4 Class I2025: 7, 4 Class I2026 (partial year): 11, 2 Class I
2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007: 1,0862008: 8,2612009: 1,9522010: 6,1332011: 41,3672012: 15,4822013: 40,0822014: 94,1802015: 26,7422016: 16,5602017: 12,0602018: 16,5912019: 15,8502020: 94,1862021: 199,3422022: 888,0202023: 165,8382024: 57,7302025: 52,792
2007high 888,020 (2022) · low 1,086 (2007)2025

MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200712102151,086
2008889248,261
20099661021,952
2010393376,133
201131036941,367
2012421742 (2)15,482
2013631222 (3)40,082
201461724 (3)94,180
20153232526,742
201633017 (1)16,560
201733051312,060
20183267116,591
20192—18 (1)15,850
20201—16 (5)94,186
20212—3 (2)199,342
202262682888,020
2023726516 (10)165,838
202451039 (4)57,730
202581727 (4)52,792
20262—11 (2)—

What is it indicated for?

The device is intended for continuous or intermittent administration of fluid through clinically acceptable routes such as epidural, intravenous, irrigation, or subcutaneous pathways. The device is intended to control and monitor the flow of fluids, which may include: 1. Drugs and Electrolytes (e.g., cardiovascular drugs, antibiotics, anesthetics, analgesics, chemotherapy agents, TPN products, lipids, solutions for irrigation procedures, etc.) 2. Whole…

Read the full statement (129 words)

The device is intended for continuous or intermittent administration of fluid through clinically acceptable routes such as epidural, intravenous, irrigation, or subcutaneous pathways. The device is intended to control and monitor the flow of fluids, which may include:

1. Drugs and Electrolytes (e.g., cardiovascular drugs, antibiotics, anesthetics, analgesics, chemotherapy agents, TPN products, lipids, solutions for irrigation procedures, etc.)

2. Whole Blood and Blood Products.

The device is intended for use in:

1. Hospitals (e.g., burn / trauma units, cardiac catheter lab, critical / intensive care, delivery / post-partum, emergency room, general floor, labor / OR / anesthesia, medical / surgical, oncology, pediatrics / neonatal, post-anesthesia / recovery, etc.)

2. Outpatient / Surgical Centers

and is intended for use by:

1. Trained health care professionals (e.g., nurses, physicians, anesthesiologists, etc.).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Fluidsense Corp.

2 FDA decisions under this applicant name. See the company

  • K003582Fluidsense Fluid Delivery System Model FS-01Fluidsense Corp. · 2000

Recent decisions in FRN

The FRN category page

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  • K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc. · 2026
  • K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation · 20251 recall
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  • K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025

https://510kreport.com/device/K982170 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982170: Fluidsense Fluid Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982170

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026