510(k) · Cleared

Cleared

Powerloc Clear Safety Infusion Set

K082306510(k) SpecialCleared Aug 28, 200815-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

C.R. Bard, Inc. · FPA Set, Administration, Intravascular

Cleared on Aug 28, 2008 as substantially equivalent to K060812 (C.R. Bard, Inc., 2006) and 1 other predicate after a 15-day review. Its family tree reaches back 7 generations to 2000. 4 later devices descend from it.

Decided: Aug 28, 2008
Review: 15 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 2

Its longest line of descent runs back 7 generations to K001901 (2000). 21 ancestors in all, the oldest K863606 (1986). 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 7 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
6 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
5 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
4 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
3 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
2 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
1 generation backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
This deviceK082306 Powerloc Clear Safety Infusion SetC.R. Bard, Inc. · 2008
Descendant · cites it directly · 2 of its ownK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
Descendant · 2 generations on · 1 of its ownK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011
Descendant · 3 generations on · 0 of its ownK192291 TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020
Descendant · cites it directly · 0 of its ownK120261 PPS PI Pressure Injectable Safety Huber Needle Without Lateral…Perouse Medical · 2012

Most influential descendants

Showing 4 of 4 · See all

K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011 · cites it directly2descendants
K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011 · 2 generations on1descendant
K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020 · 3 generations on0descendants
K120261PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS PI…Perouse Medical · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K001901	Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…	C.R. Bard, Inc.	2000	2
−6	K012902	Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…	C.R. Bard, Inc.	2001	—
−5	K031129	Poly Per-Q-Cath Picc Catheters; Poly Radpicc	C.R. Bard, Inc.	2003	—
−4	K034019	Poly Per-Q-Cath Picc Catheters	C.R. Bard, Inc.	2004	1
−3	K050931	6 FR DL Powerpicc Catheter	C.R. Bard, Inc.	2005	—
−2	K051672	Powerpicc	Bard Access Systems, Inc.	2005	1
−1	K060812	Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple	C.R. Bard, Inc.	2006	1
0 (this device)	K082306	Powerloc Clear Safety Infusion Set	C.R. Bard, Inc.	2008	—
+1	K111101	Norport CT-PC, Lucent Non-Coring Needel Infusion Set	Norfolk Medical	2011	—
+2	K112713	Norfolk Medical-Sportport-Family of Ports	Norfolk Medical Products, Inc.	2011	—
+3	K192291	TidalPort-AP Implantable Apheresis Vascular Access Port	Norfolk Medical Products, Inc.	2020	—
+1	K120261	PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site…	Perouse Medical	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1987	1	0
1989	4	0
1991	1	0
2000	1	0
2001	1	0
2004	2	0
2005	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2012	1	0
2020	1	0

FIG. 1 — Lineage of K082306, 2000–2020Source: 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 FPA? 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

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What was it cleared against? (2)

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
*	K060812	Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple Summary page 1 …ss II FPA - Intravascular Administration Set Classification Panel: General Hospital 510(k) Clearance: K060812, concurrence date 14 July 2006 6.4 Secondary Predicate Device Information Device/Trade Name: Huber Clear* S…	C.R. Bard, Inc.	2006	1
*	K051009	Huber Clear Safety Infusion Set Summary page 1 …ss II FPA - Intravascular Administration Set Classification Panel: General Hospital 510(k) Clearance: K051009, concurrence date 12 July 2005 :00e7 ==…	Now Medical Distribution, Inc.	2005	—

Also cleared against K060812: 18 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K111101	Norport CT-PC, Lucent Non-Coring Needel Infusion Set	Norfolk Medical	2011	2
K120261	PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS PI…	Perouse Medical	2012	0

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 8 years and passes through 2 companies; a new generation was cleared every 12 months on median.
11 of the 21 ancestors have a recall of any class.
Of its descendants, K111101 (Norfolk Medical, 2011) has gone furthest, with 2 descendants of its own.
18 other devices also cite its predicate K060812.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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?

The PowerLoc* Clear Safety Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle-stick safety mechanism. The device is used to access surgically implanted vascular ports. The PowerLoc* Clear Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. When used with the PowerPort* device, the…

Read the full statement (114 words)

The PowerLoc* Clear Safety Infusion Set is an intravascular administration set with a

non-coring right angle needle and manually activated needle-stick safety mechanism.

The device is used to access surgically implanted vascular ports.

The PowerLoc* Clear Safety Infusion Set is indicated for use in the administration of

fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

When used with the PowerPort* device, the PowerLoc* Clear Safety Infusion Set is

also indicated for power injection of contrast media into the central venous system. For

power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for

19 Ga. and 20 Ga. needles and 2 ml/s for 22 Ga. needles.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082306 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082306: Powerloc Clear Safety Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082306

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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