510(k) Report

510(k) · Cleared

Recalled · 2006

Palm Pump

K002434510(k) SpecialCleared Aug 23, 200014-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. · MEA Pump, Infusion, Pca

Cleared on Aug 23, 2000 after a 14-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 7 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 4 times.

Decided
Aug 23, 2000
Review
14 days
Class
Class II
Product code
MEA
Recalls
4
Predicates
0

6 later devices descend from it, 4 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2003: 2 descendants cleared2005: 1 descendant cleared2017: 1 descendant cleared2014: 1 descendant cleared, 1 with a Class I recall12016: 1 descendant cleared, 1 with a Class I recall1200020052010201520202025
  1. This deviceK002434 Palm PumpSorenson Medical, Inc. · 2000
  2. Descendant · cites it directly · 3 of its ownK033325 Ambit Continuous Ambulatory Infusion PumpSorenson Medical, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK140783 Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · Recalled (Class I)
  4. Descendant · cites it directly · 0 of its ownK162165 ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT…Summit Medical Products, Inc. · 2017 · Recalled
  5. Descendant · 3 generations on · 0 of its ownK153193 Halo II Ambulatory Infusion System (also with trade names Nimbus II…Zyno Medical, LLC · 2016 · Recalled (Class I)
  6. Descendant · cites it directly · 0 of its ownK052221 Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc. · 2005 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2003: 22005: 12014: 12016: 12017: 1
2003high 2 (2003) · low 0 (2004)2026

Class I recalls in this family

  • K140783 Halo Ambulatory Infusion System2 generations on · 2014
  • K153193 Halo II Ambulatory Infusion System (also with…3 generations on · 2016

Most influential descendants

Showing 5 of 6 · See all
  • K033325Ambit Continuous Ambulatory Infusion PumpSorenson Medical, Inc. · 2003 · cites it directly3descendants
  • K140783Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · 2 generations on1descendant
  • K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent…Summit Medical Products, Inc. · 2017 · cites it directly0descendants
  • K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion…Zyno Medical, LLC · 2016 · 3 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
0 (this device)K002434Palm PumpSorenson Medical, Inc.2000—
+1K033325Ambit Continuous Ambulatory Infusion PumpSorenson Medical, Inc.20034
+2K140783Halo Ambulatory Infusion SystemZyno Medical, LLC2014Class I
+1K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable…Summit Medical Products, Inc.20175
+3K153193Halo 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
200320
200510
201411
201611
201710
FIG. 1 — Lineage of K002434, 2000–2017Source: 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), 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.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K033325Ambit Continuous Ambulatory Infusion PumpSorenson Medical, Inc.20033
K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent…Summit Medical Products, Inc.20170
K052221Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc.20050
K033425Ambit Intermittent Ambulatory Infusion PumpSorenson Medical, Inc.20030

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 · 2 generations on · ◆ 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 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

  • Of its descendants, K033325 (Sorenson Medical, Inc., 2003) has gone furthest, with 3 descendants of its own.

How does its category compare?

All MEA devices

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

FDA decisions per year · MEA

2in 2017

2008: 12009: 12013: 12016: 12017: 2
2007high 2 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEA

Too few MEA 510(k)s in any year since 2007 to give a median.

Recalls per year · MEA

1in 2024

2008: 12010: 42011: 22014: 12017: 22022: 12024: 1
2007high 4 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MEA

3,278in 2025

2007: 812008: 2372009: 1532010: 2192011: 2452012: 4462013: 4532014: 3822015: 992016: 572017: 442018: 2562019: 1322020: 2,3312021: 3,7762022: 6,4432023: 3,9842024: 4,5592025: 3,278
2007high 6,443 (2022) · low 44 (2017)2025

MAUDE reports naming product code MEA, 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
20070—081
20081—1237
20091—0153
20100—4219
20110—2245
20120—0446
20131—0453
20140—1382
20150—099
20161—057
20172—244
20180—0256
20190—0132
20200—02,331
20210—03,776
20220—16,443
20230—03,984
20240—14,559
20250—03,278
20260—0—

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
  • K033425Ambit Intermittent Ambulatory Infusion PumpSorenson Medical, Inc. · 20031 recall
  • 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 MEA

The MEA category page

  • K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc. · 20175 recalls
  • K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110…Smiths Medical Ads, Inc. · 20175 Class I recalls
  • K143612LifeCare PCA Infusion SystemHospira, Inc. · 2016
  • K130394Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 20131 Class I recall
  • K092313Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 20094 recalls

https://510kreport.com/device/K002434 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002434: Palm Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002434

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026