510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Cue Ambulatory Volumetric Infusion Pump

K981816510(k) TraditionalCleared Dec 4, 1998196-day reviewClass II21 CFR 880.5725Recalls 56

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

Becton Dickinson Curlin, LLC · FRN Pump, Infusion

Cleared on Dec 4, 1998 as substantially equivalent to K941984 (Sabratek Corp., 1994) after a 196-day review. Its family tree reaches back 1 generation to 1994. It has been recalled 56 times.

Decided
Dec 4, 1998
Review
196 days
Class
Class II
Product code
FRN
Recalls
56
Predicates
1

Its longest line of descent runs back 1 generation to K941984 (1994). No later device cites it as a predicate yet.

K941984 · Sabratek 6060 Homerun Volumetric Infusion Pump · Sabratek Corp. · 1994 · recalled199019921994199619982000
K941984 · Sabratek 6060 Homerun Volumetric Infusion Pump · Sabratek Corp. · 1994 · recalled0
  1. Root · 1 generation backK941984 Sabratek 6060 Homerun Volumetric Infusion PumpSabratek Corp. · 1994 · Recalled
  2. This deviceK981816 Cue Ambulatory Volumetric Infusion PumpBecton Dickinson Curlin, LLC · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K941984Sabratek 6060 Homerun Volumetric Infusion PumpSabratek Corp.19941
0 (this device)K981816Cue Ambulatory Volumetric Infusion PumpBecton Dickinson Curlin, LLC1998—
FIG. 1 — Lineage of K981816, 1994–1998Source: 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? (2)

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
*K941984Sabratek 6060 Homerun Volumetric Infusion Pump
Summary page 1
…ion) Volumetric Infusion Pump Classification name: Infusion Pump Substantial equivalence claimed to: 1. Sabratek 6060 HOMERUN™ VOLUMETRIC INFUSION PUMP, 510(k) Number: K941984. : 2. Abbott Ambulatory Infusion Manager Plus (Abbott AIM® Plus), 510(k) Number: Unknown. Basic Description: The “CareMEDS5” Am…
Sabratek Corp.19941
*—Abbott Ambulatory Infusion Manager Plus (Abbott AIM® Plus)
Named without a submission number
—

Also cleared against K941984: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 27, 2019Class IIZ-2054-2019Nonconforming Material/ComponentAdministration sets leaked at the filter.
Feb 27, 2019Class IIZ-2053-2019Nonconforming Material/ComponentAdministration sets leaked at the filter.
Nov 10, 2017Class IIZ-0698-2018Nonconforming Material/ComponentParticulate found on the Curlin spike.
Nov 10, 2017Class IIZ-0697-2018Nonconforming Material/ComponentParticulate found on the Curlin spike.
Nov 10, 2017Class IIZ-0702-2018Nonconforming Material/ComponentParticulate found on the Curlin spike.
Nov 10, 2017Class IIZ-0699-2018Nonconforming Material/ComponentParticulate found on the Curlin spike.
Nov 10, 2017Class IIZ-0700-2018Nonconforming Material/ComponentParticulate found on the Curlin spike.
Nov 10, 2017Class IIZ-0701-2018Nonconforming Material/ComponentParticulate found on the Curlin spike.
Dec 23, 2015Class IIZ-0688-2016Process controlMoog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the master pumps used to calibrate them were out of tolerance and may cause an over…
Sep 26, 2012Class IIZ-0072-2013Process controlThis recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers of Curlin Administration Sets used…
May 18, 2012Not classifiedZ-1671-2012Process designMoog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
May 18, 2012Not classifiedZ-1668-2012Process designMoog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
May 18, 2012Not classifiedZ-1662-2012Process designMoog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
May 18, 2012Not classifiedZ-1664-2012Process designMoog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
May 18, 2012Not classifiedZ-1661-2012Process designMoog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
May 18, 2012Not classifiedZ-1660-2012Process designMoog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
May 18, 2012Not classifiedZ-1672-2012Process designMoog Medical Device Group became aware on March 23, 2011 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
May 18, 2012Not classifiedZ-1659-2012Process designMoog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
May 18, 2012Not classifiedZ-1665-2012Process designMoog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
May 18, 2012Not classifiedZ-1667-2012Process designMoog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
May 18, 2012Not classifiedZ-1670-2012Process designMoog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
May 18, 2012Not classifiedZ-1666-2012Process designMoog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
May 18, 2012Not classifiedZ-1669-2012Process designMoog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
May 18, 2012Not classifiedZ-1663-2012Process designMoog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
Mar 20, 2012Not classifiedZ-1401-2012Nonconforming Material/ComponentAmbulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
Feb 28, 2011Not classifiedZ-1867-2011Software designInfusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.
Feb 28, 2011Not classifiedZ-1868-2011Software designInfusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.
Feb 28, 2011Not classifiedZ-1870-2011Software designInfusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.
Feb 28, 2011Not classifiedZ-1869-2011Software designInfusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.
Jan 24, 2011Not classifiedZ-1452-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1448-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1449-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-2808-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1441-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1447-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1445-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1455-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1443-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1454-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1451-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1444-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-2809-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1440-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1453-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-2807-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1446-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1439-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1456-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1442-2011Process controlDefect in tubing may trigger false Air-In-Line warning.
Jan 24, 2011Not classifiedZ-1450-2011Process controlDefect in tubing may trigger false Air-In-Line warning.

The 5 latest of 50 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • 2 other devices also cite its predicate K941984.

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 CareMEDS™ infusion pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions. Any therapy should be overseen by a physician or a certified, licensed healthcare practitioner. The infusion pump can provide therapy to patients/users who are ambulatory and needed an alternative to receiving their medication in a restricted manner (hospital or clinic). Typically, these patients are capable of being given instruction…

Read the full statement (176 words)

The CareMEDS™ infusion pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions. Any therapy should be overseen by a physician or a certified, licensed healthcare practitioner. The infusion pump can provide therapy to patients/users who are ambulatory and needed an alternative to receiving their medication in a restricted manner (hospital or clinic).

Typically, these patients are capable of being given instruction for performing basic tasks in operating the pump and maintaining medical care for themselves, or are assisted in these tasks by having a caregiver closely by, or living with them. All patients and caregivers must be instructed in the use of the CareMEDS5™ by a qualified clinician and demonstrate an adequate level of proficiency in the use of the pump.

The CareMED5™ is small, lightweight and is designed to have exceptional ease of use so theat after learning the pump features and basic of programming, the pump can be operated and can be customized to the specific needs of each individual patient without the need to constantly refer to the User’s Manual.

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 K941984

2 other devices cite the same predicate.

  • K980751Sabratek 4040 Infusion PumpSabratek Corp. · 1999
  • K981776Alexander Manufacturing CO. Battery Part Number MC146XAlexander Mfg. Co. · 1998

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/K981816 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981816: Cue Ambulatory Volumetric Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981816

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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