510(k) Report

510(k) · Cleared

Recalled · 2006

Ambit Continuous Ambulatory Infusion Pump

K033325510(k) SpecialCleared Nov 6, 200321-day reviewClass II21 CFR 880.5725Recalls 4

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

Sorenson Medical, Inc. · FRN Pump, Infusion

Cleared on Nov 6, 2003 as substantially equivalent to K002434 (Sorenson Medical, Inc., 2000) after a 21-day review. Its family tree reaches back 1 generation to 2000. 2 of the 5 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 4 times.

Decided
Nov 6, 2003
Review
21 days
Class
Class II
Product code
FRN
Recalls
4
Predicates
1

Its longest line of descent runs back 1 generation to K002434 (2000). 3 later devices descend from it, 2 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2005: 1 descendant cleared2014: 1 descendant cleared, 1 with a Class I recall12016: 1 descendant cleared, 1 with a Class I recall1K002434 · Palm Pump · Sorenson Medical, Inc. · 2000 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants, 1 with a Class I recall12 generations forward: 1 descendant, 1 with a Class I recall1 K002434 · Palm Pump · Sorenson Medical, Inc. · 2000 · recalled0
  1. Root · 1 generation backK002434 Palm PumpSorenson Medical, Inc. · 2000 · Recalled
  2. This deviceK033325 Ambit Continuous Ambulatory Infusion PumpSorenson Medical, Inc. · 2003
  3. Descendant · cites it directly · 1 of its ownK140783 Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · Recalled (Class I)
  4. Descendant · 2 generations on · 0 of its ownK153193 Halo II Ambulatory Infusion System (also with trade names Nimbus II…Zyno Medical, LLC · 2016 · Recalled (Class I)
  5. Descendant · cites it directly · 0 of its ownK052221 Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc. · 2005 · Recalled

Class I recalls in this family

  • K140783 Halo Ambulatory Infusion Systemcites it directly · 2014
  • K153193 Halo II Ambulatory Infusion System (also with…2 generations on · 2016

Most influential descendants

Showing 3 of 3 · See all
  • K140783Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · cites it directly1descendant
  • K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion…Zyno Medical, LLC · 2016 · 2 generations on0descendants
  • K052221Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002434Palm PumpSorenson Medical, Inc.20004
0 (this device)K033325Ambit Continuous Ambulatory Infusion PumpSorenson Medical, Inc.2003—
+1K140783Halo Ambulatory Infusion SystemZyno Medical, LLC2014Class I
+2K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory…Zyno Medical, LLC2016Class I
+1K052221Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc.20054

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201411
201611
FIG. 1 — Lineage of K033325, 2000–2016Source: 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.

2 devices in this family have a Class I recall. 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? (1)

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
*K002434Palm Pump
Summary page 1
…mp is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The modified device differs only slightly from the Palm Pumps (K002434) already marketed. Changes have been made to that pump to incorporate three roller gears instead of two, a modified PCB, a change…
Sorenson Medical, Inc.20004

Also cleared against K002434: 3 other devices →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140783Halo Ambulatory Infusion System Class IZyno Medical, LLC20141
K052221Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc.20050

Has anything in its family been recalled? (2 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 10, 2006Not classifiedZ-0185-2007OtherSterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
Oct 10, 2006Not classifiedZ-0186-2007OtherSterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
Oct 10, 2006Not classifiedZ-0188-2007OtherSterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
Oct 10, 2006Not classifiedZ-0187-2007OtherSterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K140783Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
  • K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA…Zyno Medical, LLC · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K140783 (Zyno Medical, LLC, 2014) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K002434.

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 amblTrM Infusion Pump is intended for continuous volumetric delivery of intravenous medicines and/or fluids into patients at a consistent volume for prescriptive treatment by a physician.

Indications for use as stated in the FDA summary.

Also cleared against K002434

3 other devices cite the same predicate.

  • K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc. · 20175 recalls
  • K052221Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc. · 20054 recalls
  • K033425Ambit Intermittent Ambulatory Infusion PumpSorenson Medical, Inc. · 20031 recall

More from Sorenson Medical, Inc.

6 FDA decisions under this applicant name. See the company

  • K052221Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc. · 20054 recalls
  • K033425Ambit Intermittent Ambulatory Infusion PumpSorenson Medical, Inc. · 20031 recall
  • K002434Palm PumpSorenson Medical, Inc. · 20004 recalls
  • K001287Empty Reservoir Bag, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 MLSorenson Medical, Inc. · 2000
  • K99136330 Pump, Continuous Low Flow, 200 Pump, Intermittent with Kvo or Continuous, Pca Pump, Pain Management, Pcea…Sorenson Medical, Inc. · 1999

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/K033325 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033325: Ambit Continuous Ambulatory 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/K033325

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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