510(k) · Cleared

Cleared

Bard NO-Rinse Hemoconcentrator and Accessory Kit

K971180510(k) TraditionalCleared Jul 24, 1997115-day reviewClass II21 CFR 876.5860

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. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Jul 24, 1997 after a 115-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Jul 24, 1997
Review: 115 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK971180 Bard NO-Rinse Hemoconcentrator and Accessory KitC.R. Bard, Inc. · 1997
Descendant · cites it directly · 1 of its ownK974584 Fresenius F Series Hemoconcentrators…Fresenius USA, Inc. · 1998
Descendant · 2 generations on · 0 of its ownK992275 Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified…Fresenius USA, Inc. · 1999

Most influential descendants

Showing 2 of 2 · See all

K974584Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TSFresenius USA, Inc. · 1998 · cites it directly1descendant
K992275Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol…Fresenius USA, Inc. · 1999 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K971180	Bard NO-Rinse Hemoconcentrator and Accessory Kit	C.R. Bard, Inc.	1997	—
+1	K974584	Fresenius F Series Hemoconcentrators…	Fresenius USA, Inc.	1998	—
+2	K992275	Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low…	Fresenius USA, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0

FIG. 1 — Lineage of K971180, 1997–1999Source: 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 KDI? 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 KDI device

#1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 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	Recalls
*	—	Fresenius Hemoflow F40 Capillary Dialyzer Named without a submission number	—
*	—	Bard Hemoconcentrator with Tubing Set, HC70TS Named without a submission number	—
*	—	Research Medical Hemoconcentrator, Biofilter 140 Named without a submission number	—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K974584	Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS	Fresenius USA, Inc.	1998	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?

Of its descendants, K974584 (Fresenius USA, Inc., 1998) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KDI devices

KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KDI

9in 2025

2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007high 266 (2020) · low 69 (2015)2026

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

Recalls per year · KDI

2in 2025

2007high 17 (2022) · low 0 (2008)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · KDI

2,786in 2025

2007high 6,154 (2014) · low 522 (2009)2025

MAUDE reports naming product code KDI, 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	11	91	4	916
2008	6	148	0	1,042
2009	4	236	3	522
2010	9	186	1	823
2011	5	85	4	2,270
2012	6	153	1	1,765
2013	11	247	2	2,360
2014	8	164	3	6,154
2015	5	69	5	4,182
2016	5	230	4	766
2017	8	188	1	963
2018	2	—	1	1,716
2019	4	263	6	1,587
2020	9	266	0	1,633
2021	2	—	2	1,944
2022	7	259	17	2,180
2023	7	157	8 (8)	2,692
2024	7	235	4 (2)	2,441
2025	9	199	2	2,786
2026	6	154	2	—

What is it indicated for?

The Bard® No-rinse Hemoconcentrator is intended for the relief

or mitigation of overhydration in patients undergoing

cardiopulmonary procedures and to increase the concentration of

cells and proteins in the blood.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971180 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971180: Bard NO-Rinse Hemoconcentrator and Accessory Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971180

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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