510(k) · Cleared

Cleared

PD-IO Disposable Intraosseous Infusion Needle

K043490510(k) TraditionalCleared Feb 18, 200563-day reviewClass II21 CFR 880.5570

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

Vidacare Corporation · FMI Needle, Hypodermic, Single Lumen

Cleared on Feb 18, 2005 as substantially equivalent to K032885 (Vidacare Corporation, 2004) and 2 other predicates after a 63-day review. Its family tree reaches back 2 generations to 1992. 16 later devices descend from it.

Decided: Feb 18, 2005
Review: 63 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K915409 (1992). 5 ancestors in all, the oldest K913258 (1992). 16 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK915409 Intraosseous Access NeedleCook, Inc. · 1992
1 generation backK022415 Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 2002
This deviceK043490 PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005
Descendant · cites it directly · 13 of its ownK052195 EZ-Mio Manual DriverVidacare Corporation · 2005
Descendant · 2 generations on · 3 of its ownK080865 FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008
Descendant · 2 generations on · 3 of its ownK062956 EZ-Mio, EZ-IO Distal TibiaVidacare Corporation · 2006
Descendant · cites it directly · 3 of its ownK051992 Powered PD-IO Intraosseous Infusion SystemVidacare Corporation · 2005
Descendant · 3 generations on · 2 of its ownK100124 Fastx Sternal Intraosseous DevicePyng Medical Corp. · 2010 · Recalled

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2005high 3 (2006) · low 0 (2011)2026

Most influential descendants

Showing 5 of 16 · See all

K052195EZ-Mio Manual DriverVidacare Corporation · 2005 · cites it directly13descendants
K080865FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008 · 2 generations on3descendants
K062956EZ-Mio, EZ-IO Distal TibiaVidacare Corporation · 2006 · 2 generations on3descendants
K051992Powered PD-IO Intraosseous Infusion SystemVidacare Corporation · 2005 · cites it directly3descendants
K100124Fastx Sternal Intraosseous DevicePyng Medical Corp. · 2010 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K915409	Intraosseous Access Needle	Cook, Inc.	1992	—
−1	K022415	Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST	Waismed, Ltd.	2002	—
0 (this device)	K043490	PD-IO Disposable Intraosseous Infusion Needle	Vidacare Corporation	2005	—
+1	K052195	EZ-Mio Manual Driver	Vidacare Corporation	2005	—
+2	K080865	FAST1 Intraosseous Infusion System	Pyng Medical Corp.	2008	—
+2	K062956	EZ-Mio, EZ-IO Distal Tibia	Vidacare Corporation	2006	—
+1	K051992	Powered PD-IO Intraosseous Infusion System	Vidacare Corporation	2005	—
+3	K100124	Fastx Sternal Intraosseous Device	Pyng Medical Corp.	2010	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1998	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	3	0
2007	1	0
2008	1	0
2009	1	0
2010	2	0
2012	1	0
2013	1	0
2014	1	0
2018	1	0
2019	1	0
2021	1	0

FIG. 1 — Lineage of K043490, 1992–2021Source: 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 FMI? 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 FMI device

#1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

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
*	K032885	Vidaport Intraosseous Infusion System Summary page 1 …dermic single lumen needle The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: VidaCare Corporation, EZ-10 t lntraosseous Infusion System, K032885 Cook, Inc., Disposable lntraosseous Infusion Needles, K913258 WaisMed BIG for Pediatrics, K022415 Description of the device:…	Vidacare Corporation	2004	—
*	K913258	Disposable Introsseous Infusion Needles Summary page 1 …ch we are claiming equivalence [807.92(a)(3)]: VidaCare Corporation, EZ-10 t lntraosseous Infusion System, K032885 Cook, Inc., Disposable lntraosseous Infusion Needles, K913258 WaisMed BIG for Pediatrics, K022415 Description of the device: The PD-1O Disposable lntraosseous Infusion Needle and Han…	Cook, Inc.	1992	—
*	K022415	Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST Summary page 1 …92(a)(3)]: VidaCare Corporation, EZ-10 t lntraosseous Infusion System, K032885 Cook, Inc., Disposable lntraosseous Infusion Needles, K913258 WaisMed BIG for Pediatrics, K022415 Description of the device: The PD-1O Disposable lntraosseous Infusion Needle and Handle consists of a sterile sin…	Waismed, Ltd.	2002	—

Also cleared against K032885: 7 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K052195	EZ-Mio Manual Driver	Vidacare Corporation	2005	13
K051992	Powered PD-IO Intraosseous Infusion System	Vidacare Corporation	2005	3
K063142	Manual PD-IO; Powered PD-IO	Vidacare Corporation	2006	2
K190538	NIO-I	Waismed, Ltd.	2019	1

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K052195 (Vidacare Corporation, 2005) has gone furthest, with 13 descendants of its own.
7 other devices also cite its predicate K032885.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMI

11in 2025

2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007high 263 (2020) · low 71 (2007)2026

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

Recalls per year · FMI

1in 2024

2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, 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	15	71	2	208
2008	10	85	4	177
2009	7	177	3	263
2010	15	119	79	249
2011	12	113	5	240
2012	17	107	1	215
2013	11	87	1	255
2014	14	155	3	287
2015	10	89	1	567
2016	20	217	0	941
2017	9	253	16	1,547
2018	20	176	0	2,398
2019	12	186	5	4,896
2020	11	263	3	4,245
2021	18	143	7	4,532
2022	23	189	0	4,885
2023	18	112	2	4,986
2024	3	90	1	4,053
2025	11	141	0	2,424
2026	12	119	1 (1)	—

What is it indicated for?

The PD-10 Disposable Intraosseous Infusion Needle and Handle provides

intraosseous access in the proximal tibia, as an alternative to IV access during

emergencies. The device is for use in pediatric patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043490 · printed Nov 5, 2026

Cite this page

510(k) Report. “K043490: PD-IO Disposable Intraosseous Infusion Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043490

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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