510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump

K162165510(k) TraditionalCleared Aug 29, 2017391-day reviewClass II21 CFR 880.5725Recalls 5

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

Summit Medical Products, Inc. · MEA Pump, Infusion, Pca

Cleared on Aug 29, 2017 as substantially equivalent to K002434 (Sorenson Medical, Inc., 2000) after a 391-day review. Its family tree reaches back 1 generation to 2000. It has been recalled 5 times.

Decided
Aug 29, 2017
Review
391 days
Class
Class II
Product code
MEA
Recalls
5
Predicates
1

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

Reference device: K130394 · Cadd -Solis Ambulatory Infusion Pump, Version 3.0 · Smiths Medical Asd, Inc. · 2013 · Class I recallK002434 · Palm Pump · Sorenson Medical, Inc. · 2000 · recalled2000200520102015
K002434 · Palm Pump · Sorenson Medical, Inc. · 2000 · recalled0
  1. Root · 1 generation backK002434 Palm PumpSorenson Medical, Inc. · 2000 · Recalled
  2. This deviceK162165 ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT…Summit Medical Products, Inc. · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002434Palm PumpSorenson Medical, Inc.20004
0 (this device)K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable…Summit Medical Products, Inc.2017—
FIG. 1 — Lineage of K162165, 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), 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 MEA? 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? (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 4
…ion Pump or Infusion Pump Classification Name: Infusion Pump Regulation Number: 21 CFR 80.5725 Product Codes: MEA, PCA Infusion Pump FRN, Infusion Pump Predicate Device K002434—ambIT® PCA Pump Reference Device K130394 – CADD®-Solis Ambulatory Infusion Pump Device Description The new ambIT PCA*PIB is an…
Sorenson Medical, Inc.20004
†K130394Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc.2013Class I

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
Apr 24, 2023Class IIZ-1688-2023Under Investigation by firmSome of the ambIT kits were potentially distributed without an air in-line filter.
Apr 24, 2023Class IIZ-1687-2023Under Investigation by firmSome of the ambIT kits were potentially distributed without an air in-line filter.
Apr 24, 2023Class IIZ-1684-2023Under Investigation by firmSome of the ambIT kits were potentially distributed without an air in-line filter.
Apr 24, 2023Class IIZ-1686-2023Under Investigation by firmSome of the ambIT kits were potentially distributed without an air in-line filter.
Apr 24, 2023Class IIZ-1685-2023Under Investigation by firmSome of the ambIT kits were potentially distributed without an air in-line filter.

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 MEA devices

MEA Pump, Infusion, Pca: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

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—

What is it indicated for?

The ambIT PCA*PIB Pump is used to infuse medicines and/or fluids into patients primarily for pain management.

The routes of administration are generally intravenous, epidural and/or regional.

The ambIT PCA*PIB Pump is not intended to supersede, augment, or replace any other medical device or drug indications for use or intended uses.

The ambIT PCA*PIB Pump is intended to be used in the home and in healthcare facilities.

Indications for use as stated in the FDA summary.

Also cleared against K002434

3 other devices cite the same predicate.

  • 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

More from Summit Medical Products, Inc.

4 FDA decisions under this applicant name. See the company

  • K113043Direct Antibiotic Infusion KitSummit Medical Products, Inc. · 2011
  • K110814Ambit TunnelerSummit Medical Products, Inc. · 2011
  • K102460Ambit Introducer, Ambit Needle, Ambit SheathSummit Medical Products, Inc. · 2011

Recent decisions in MEA

The MEA category page

  • 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
  • K072144Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - AdministratorSmiths Medical MD, Inc. · 20082 Class I recalls

https://510kreport.com/device/K162165 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162165: ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162165

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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