510(k) · Cleared

Cleared

Perfudrop Air M-P with Needle 20 G, Model 48451606

K041919510(k) AbbreviatedCleared Oct 4, 200480-day reviewClass II21 CFR 880.5440

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

Clinico · FPA Set, Administration, Intravascular

Cleared on Oct 4, 2004 as substantially equivalent to K022209 (Alaris Medical Systems, Inc., 2002) after an 80-day review. Its family tree reaches back 1 generation to 2002. 1 of the 2 devices in its family, counting itself, has a Class I recall.

Decided: Oct 4, 2004
Review: 80 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K022209 (2002). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK022209 Alaris Medical Infusion System Administration SetsAlaris Medical Systems, Inc. · 2002 · Recalled (Class I)
This deviceK041919 Perfudrop Air M-P with Needle 20 G, Model 48451606Clinico · 2004

Class I recalls in this family

K022209 Alaris Medical Infusion System Administration Setsdirect predicate · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K022209	Alaris Medical Infusion System Administration Sets	Alaris Medical Systems, Inc.	2002	Class I
0 (this device)	K041919	Perfudrop Air M-P with Needle 20 G, Model 48451606	Clinico	2004	—

FIG. 1 — Lineage of K041919, 2002–2004Source: 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.

1 device in this family has 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 FPA device

#1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K022209	Alaris Medical Infusion System Administration Sets Summary page 1 …name of device: b) Regulation number: 880.5440 Predicate device: Gemini IV Administration Sets, Alaris (Premarket notification K022209) Description of the The Perfudrop ® Air M-P intravascular administration set: set (model no. 48451606)…	Alaris Medical Systems, Inc.	2002	Class I

Also cleared against K022209: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

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.

K022209Alaris Medical Infusion System Administration SetsAlaris Medical Systems, Inc. · 2002 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls

What does this lineage say?

Its one ancestor has a recall, Class I.
1 other device also cites its predicate K022209.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

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

Recalls per year · FPA

98in 2025

2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, 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	16	75	17	1,499
2008	18	89	15	1,941
2009	10	166	166	2,512
2010	23	120	58	2,537
2011	12	87	28	4,407
2012	21	96	16 (4)	4,930
2013	13	90	64	4,651
2014	22	89	24	4,695
2015	17	123	6	6,625
2016	12	195	10	8,470
2017	17	240	13	6,462
2018	4	177	4	6,574
2019	7	161	13	11,227
2020	10	327	107	9,563
2021	13	186	1	10,414
2022	14	213	9 (5)	13,393
2023	14	340	12 (4)	10,916
2024	7	244	13 (1)	47,210
2025	11	225	98 (1)	34,506
2026	5	266	10 (2)	—

What is it indicated for?

Perfudrop® Air M-P with Needle is an intravascular administration set to administer IV fluids and pharmaceuticals from a container to a patient's vascular system through a needle inserted into a vein.

The administration set is for use under gravity and pressure conditions.

The set is not intended nor indicated for use with blood or blood products.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041919 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041919: Perfudrop Air M-P with Needle 20 G, Model 48451606.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041919

Report an extraction error

Are you the manufacturer?

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