510(k) · Cleared

Cleared

SAM CRRT Unit, SAM Cassette CRRT

K170790510(k) AbbreviatedCleared Dec 13, 2017272-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

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

Cleared on Dec 13, 2017 as substantially equivalent to K110823 (Gambro Renal Products, Inc., 2011) after a 272-day review. Its family tree reaches back 2 generations to 2006.

Decided: Dec 13, 2017
Review: 272 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K062090 (2006). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK062090 Prisma System R03.10AGambro Renal Products · 2006
1 generation backK110823 PrismaflexGambro Renal Products, Inc. · 2011 · Recalled
This deviceK170790 SAM CRRT Unit, SAM Cassette CRRTSpectral Medical, Inc. · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K062090	Prisma System R03.10A	Gambro Renal Products	2006	—
−1	K110823	Prismaflex	Gambro Renal Products, Inc.	2011	9
0 (this device)	K170790	SAM CRRT Unit, SAM Cassette CRRT	Spectral Medical, Inc.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K170790, 2006–2017Source: 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? (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
*	K110823	Prismaflex Summary page 4 …m Regulatory Class: Class II Product Code: KDI Classification Panel: Gastroenterology/Urology Legally Marketed Predicate Devices (unmodified devices) Prismaflex™ 510(k) K110823 Device Description The S.A.M CRRT Unit is a software controlled device that performs the following functions: - Primes the SA…	Gambro Renal Products, Inc.	2011	9

What descends from it?

No later submission names this one as a predicate yet.

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 11 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
2 of the 3 ancestors have a recall of any class.

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. 2017, this device’s year, is highlighted.

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 S.A.M CRRT Unit is intended for: * Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. * Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. For all treatments performed utilizing the S.A.M CRRT Unit, use of the treatment device must be carried out as per the manufacturers’…

Read the full statement (146 words)

The S.A.M CRRT Unit is intended for:

* Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.

* Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.

For all treatments performed utilizing the S.A.M CRRT Unit, use of the treatment device must be carried out as per the manufacturers’ specifications.

All treatments administered via the S.A.M unit must be prescribed by a physician and are intended to be performed in the environment of the Intensive Care Unit or Emergency Department of the hospital.

Rx Only.

The S.A.M Cassette CRRT is intended for single use in continuous renal replacement and therapeutic plasma exchange therapies using the S.A.M CRRT Unit. The S.A.M Cassette for CRRT is indicated for patients weighing 20 kg or more.

Rx Only.

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/K170790 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170790: SAM CRRT Unit, SAM Cassette CRRT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170790

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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