510(k) · Cleared

Cleared

8810 Pump-Pump Single Needle Device

K873279510(k) TraditionalCleared Oct 23, 198767-day reviewClass II21 CFR 876.5820

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

Cd Medical, Inc. · FIF Set, Dialysis, Single Needle With Uni-Directional Pump

Cleared on Oct 23, 1987 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided: Oct 23, 1987
Review: 67 days
Class: Class II
Product code: FIF
Recalls: None
Predicates: 0

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

This deviceK873279 8810 Pump-Pump Single Needle DeviceCd Medical, Inc. · 1987
Descendant · cites it directly · 12 of its ownK955384 Drake Willock System 1000 Dialysate Delivery System W/Single Needle…Althin Medical AB an Affiliate of Baxter Intl · 1997
Descendant · 2 generations on · 11 of its ownK970446 Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1997 · Recalled
Descendant · 3 generations on · 9 of its ownK993064 Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 1999 · Recalled
Descendant · 4 generations on · 8 of its ownK021615 Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · Recalled
Descendant · 5 generations on · 4 of its ownK041005 Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · Recalled

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1997high 2 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 13 · See all

K955384Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen OptionAlthin Medical AB an Affiliate of Baxter Intl · 1997 · cites it directly12descendants
K970446Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1997 · 2 generations on11descendants
K993064Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 1999 · 3 generations on9descendants
K021615Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · 4 generations on8descendants
K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · 5 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K873279	8810 Pump-Pump Single Needle Device	Cd Medical, Inc.	1987	—
+1	K955384	Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single…	Althin Medical AB an Affiliate of Baxter Intl	1997	—
+2	K970446	Drake Willock System & Altra Touch 1000 Dialysis Delivery System	Althin Medical AB an Affiliate of Baxter Intl	1997	5
+3	K993064	Prisma CFM (Continuous Fluid Management System)	Gambro Renal Care Products	1999	1
+4	K021615	Baxter Accura System, Model 5M5660	Baxter Healthcare Corp	2002	3
+5	K041005	Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets	Gambro Renal Products	2004	7

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
1999	1	0
2002	2	0
2004	1	0
2005	1	0
2007	2	0
2008	1	0
2009	1	0
2022	2	0

FIG. 1 — Lineage of K873279, 1987–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FIF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K955384	Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen Option	Althin Medical AB an Affiliate of Baxter Intl	1997	12

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, K955384 (Althin Medical AB an Affiliate of Baxter Intl, 1997) has gone furthest, with 12 descendants of its own.

How does its category compare?

All FIF devices

FIF Set, Dialysis, Single Needle With Uni-Directional Pump: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FIF

FDA has decided no FIF device since 2007.

Median 510(k) review, days · FIF

Too few FIF 510(k)s in any year since 2007 to give a median.

Recalls per year · FIF

No recall names FIF since 2007.

Adverse event reports per year · FIF

3in 2007

2007high 3 (2007) · low 0 (2008)2025

MAUDE reports naming product code FIF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	3
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K873279 · printed Nov 5, 2026

Cite this page

510(k) Report. “K873279: 8810 Pump-Pump Single Needle Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K873279

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026