510(k) Report

510(k) · Cleared

Recalled · 2006

Ambit Intermittent Ambulatory Infusion Pump

K033425510(k) SpecialCleared Nov 6, 200310-day reviewClass II21 CFR 880.5725Recalls 1

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 10-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.

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

Its longest line of descent runs back 1 generation to K002434 (2000). No later device cites it as a predicate yet.

K002434 · Palm Pump · Sorenson Medical, Inc. · 2000 · recalled200020022004
K002434 · Palm Pump · Sorenson Medical, Inc. · 2000 · recalled0
  1. Root · 1 generation backK002434 Palm PumpSorenson Medical, Inc. · 2000 · Recalled
  2. This deviceK033425 Ambit Intermittent Ambulatory Infusion PumpSorenson Medical, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002434Palm PumpSorenson Medical, Inc.20004
0 (this device)K033425Ambit Intermittent Ambulatory Infusion PumpSorenson Medical, Inc.2003—
FIG. 1 — Lineage of K033425, 2000–2003Source: 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? (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
Our reading of the summary gave K002334, FDA’s number for Macroporens Craniloc (Macropore Biosurgery, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Palm Pump”.
Sorenson Medical, Inc.20004

Also cleared against K002434: 3 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
May 3, 2006Not classifiedZ-1188-06OtherIntermittent Infusion pump may continually dispense medication under certain conditions.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • 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 ambIT™ Intermittent Ambulatory Infusion Pump is intended for the Intermittent volumetric delivery of intravenous medicines and/or fluids into patients at predetermined rates and volumes 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
  • K033325Ambit Continuous Ambulatory Infusion PumpSorenson Medical, Inc. · 20034 recalls

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
  • K033325Ambit Continuous Ambulatory Infusion PumpSorenson Medical, Inc. · 20034 recalls
  • 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/K033425 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033425: Ambit Intermittent Ambulatory Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033425

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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