510(k) Report

510(k) · Cleared

Cleared

Advantis Asc Infusion Pump and Administration Sets

K993524510(k) TraditionalCleared Aug 1, 2000288-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

Alaris Medical Systems, Inc. · FRN Pump, Infusion

Cleared on Aug 1, 2000 as substantially equivalent to K914589 (Sabratek Corp., 1992) and 2 other predicates after a 288-day review. Its family tree reaches back 1 generation to 1979.

Decided
Aug 1, 2000
Review
288 days
Class
Class II
Product code
FRN
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K792538 (1979). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1992: 2 other ancestorsReference device: K913895 · Flo-Gard (R) 6200, 6300 & 8000 · Baxter Healthcare Corp · 1991 · recalledK792538 · Continu-Flo Admin. Set Code 2C/200 · Travenol Laboratories, S.A. · 1979197519801985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K792538 · Continu-Flo Admin. Set Code 2C/200 · Travenol Laboratories, S.A. · 19790
  1. Root · 1 generation backK792538 Continu-Flo Admin. Set Code 2C/200Travenol Laboratories, S.A. · 1979
  2. This deviceK993524 Advantis Asc Infusion Pump and Administration SetsAlaris Medical Systems, Inc. · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K792538Continu-Flo Admin. Set Code 2C/200Travenol Laboratories, S.A.1979—
0 (this device)K993524Advantis Asc Infusion Pump and Administration SetsAlaris Medical Systems, Inc.2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
FIG. 1 — Lineage of K993524, 1979–2000Source: 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
*K914589Sabratek 3030 Infusion Pump
Summary page 1
…mon Name: Infusion Pump and Administration Set Classification Name: Infusion Pump and Intravascular Administration Set Sabratek Corporation Sabratek 3030 Infusion Pump K914589 Baxter Healthcare Corporation Flo-Gard 6201 Infusion Pump K915522 Baxter (under Travenol Laboratories) Continu-Flo Admin Set, C…
Sabratek Corp.1992—
*K915522Flo-Gard (R) 6201
Summary page 1
…: Infusion Pump and Intravascular Administration Set Sabratek Corporation Sabratek 3030 Infusion Pump K914589 Baxter Healthcare Corporation Flo-Gard 6201 Infusion Pump K915522 Baxter (under Travenol Laboratories) Continu-Flo Admin Set, Code 2C/200 K792538 The Advantis™ ASC (Alternate Site Care) is a mu…
Baxter Healthcare Corp19926
*K792538Continu-Flo Admin. Set Code 2C/200
Summary page 1
…ek 3030 Infusion Pump K914589 Baxter Healthcare Corporation Flo-Gard 6201 Infusion Pump K915522 Baxter (under Travenol Laboratories) Continu-Flo Admin Set, Code 2C/200 K792538 The Advantis™ ASC (Alternate Site Care) is a multi-mode large volume infusion pump suitable for general and homecare application…
Travenol Laboratories, S.A.1979—
†K300699Flo-Gard 6300 Blood Pumping Indication—
†K913895Flo-Gard (R) 6200, 6300 & 8000Baxter Healthcare Corp19911

Also cleared against K914589: 1 other device →

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?

  • 1 of the 3 ancestors has a recall of any class.
  • 1 other device also cites its predicate K914589.

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 Advantis ASC is intended to be used for intravascular administration of drugs, fluids, blood and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application.

ALARIS Medical’s policy is to not indicate specific drugs and/or fluids except in cases when a device is designed specifically or solely for a particular drug or fluid. Consistent with this policy, we would contraindicate drugs and/or fluids as appropriate for the Advantis ASC. No such contraindications have been identified.

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

Also cleared against K914589

1 other device cites the same predicate.

  • K980751Sabratek 4040 Infusion PumpSabratek Corp. · 1999

More from Alaris Medical Systems, Inc.

16 FDA decisions under this applicant name. See the company

  • K043299Medley Pca Module, Model 8120Alaris Medical Systems, Inc. · 20041 Class I recall
  • K041241Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 20041 Class I recall
  • K031741Medley ETCO2 Module (Includes Accessories), Model 8300Alaris Medical Systems, Inc. · 20042 recalls
  • K032233Medley Pca Module, Model 8120Alaris Medical Systems, Inc. · 20033 recalls
  • K032147Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX SeriesAlaris Medical Systems, Inc. · 20031 recall

Recent decisions in FRN

The FRN category page

  • K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026
  • 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
  • K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 20251 recall
  • K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025

https://510kreport.com/device/K993524 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993524: Advantis Asc Infusion Pump and Administration Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993524

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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