510(k) · Cleared

Recalled · 2006

Ambit Push & Play Ambulatory Infusion Pump

K052221510(k) AbbreviatedCleared Dec 8, 2005115-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 Dec 8, 2005 as substantially equivalent to K965222 (Microject, Inc., 1997) and 3 other predicates after a 115-day review. Its family tree reaches back 2 generations to 2000. It has been recalled 4 times.

Decided: Dec 8, 2005
Review: 115 days
Class: Class II
Product code: FRN
Recalls: 4
Predicates: 4

Its longest line of descent runs back 2 generations to K002434 (2000). 7 ancestors in all, the oldest K965222 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK002434 Palm PumpSorenson Medical, Inc. · 2000 · Recalled
1 generation backK033325 Ambit Continuous Ambulatory Infusion PumpSorenson Medical, Inc. · 2003 · Recalled
This deviceK052221 Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K002434	Palm Pump	Sorenson Medical, Inc.	2000	4
−1	K033325	Ambit Continuous Ambulatory Infusion Pump	Sorenson Medical, Inc.	2003	4
0 (this device)	K052221	Ambit Push & Play Ambulatory Infusion Pump	Sorenson Medical, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2003	2	0
2004	2	0

FIG. 1 — Lineage of K052221, 2000–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
#2 Held for the reportin the report
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What was it cleared against? (4)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K965222	Microject Model Pca-1 Summary page 1 …Pump/Class II, 80FRN - 21 CFR 880.5725 Trade Names: amnbIT® PreSet Ambulatory Infusion Pump, or amnbIT® Pump Predicate Devices: * The MicroJect PCA Pump K965222 * The Palm Pump, K002434 * The ambIT® Continuous Ambulatory Infusion Pump K033325. Note: These predicate device…	Microject, Inc.	1997	—
*	K002434	Palm Pump Summary page 1 …0.5725 Trade Names: amnbIT® PreSet Ambulatory Infusion Pump, or amnbIT® Pump Predicate Devices: * The MicroJect PCA Pump K965222 * The Palm Pump, K002434 * The ambIT® Continuous Ambulatory Infusion Pump K033325. Note: These predicate devices are manufactured by Sorenson M…	Sorenson Medical, Inc.	2000	4
*	K033325	Ambit Continuous Ambulatory Infusion Pump Summary page 1 …, or amnbIT® Pump Predicate Devices: * The MicroJect PCA Pump K965222 * The Palm Pump, K002434 * The ambIT® Continuous Ambulatory Infusion Pump K033325. Note: These predicate devices are manufactured by Sorenson Medical, Inc. * Stryker Pain Pumps 1 & 2 K042405. Not…	Sorenson Medical, Inc.	2003	4
*	K042405	PAINPUMP1; PAINPUMP2 Summary page 1 …* The ambIT® Continuous Ambulatory Infusion Pump K033325. Note: These predicate devices are manufactured by Sorenson Medical, Inc. * Stryker Pain Pumps 1 & 2 K042405. Note: These pumps are manufactured by Stryker Instruments. Statement of Intended Use: The amnbIT® PreSet Ambulatory Inf…	Stryker Corp.	2004	70

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

Date	Class	Recall	Root cause	Reason
Oct 10, 2006	Not classified	Z-0185-2007	Other	Sterile 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, 2006	Not classified	Z-0186-2007	Other	Sterile 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, 2006	Not classified	Z-0188-2007	Other	Sterile 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, 2006	Not classified	Z-0187-2007	Other	Sterile 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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
4 of the 7 ancestors have a recall of any class.

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

2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007high 312 (2013) · low 66 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRN

7in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	12	102	15	1,086
2008	8	89	24	8,261
2009	9	66	102	1,952
2010	3	93	37	6,133
2011	3	103	69	41,367
2012	4	217	42 (2)	15,482
2013	6	312	22 (3)	40,082
2014	6	172	4 (3)	94,180
2015	3	232	5	26,742
2016	3	301	7 (1)	16,560
2017	3	305	13	12,060
2018	3	267	1	16,591
2019	2	—	18 (1)	15,850
2020	1	—	16 (5)	94,186
2021	2	—	3 (2)	199,342
2022	6	268	2	888,020
2023	7	265	16 (10)	165,838
2024	5	103	9 (4)	57,730
2025	8	172	7 (4)	52,792
2026	2	—	11 (2)	—

What is it indicated for?

The ambIT® "PreSet" Ambulatory Infusion Pump is intended for use by surgeons and anesthesiologists for the perioperative and post operative infusion of local anesthetics and narcotics for pain management and regional anesthesia.

Routes of administration include intravenous, subcutaneous, intramuscular, perineural and epidural.

The ambIT® "PreSet" Ambulatory Infusion Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052221 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052221: Ambit Push & Play 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/K052221

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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