510(k) · Cleared

Cleared

Biologic DT-1000 Machine

K923046510(k) TraditionalCleared Sep 30, 1994828-day reviewClass II21 CFR 876.5980

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

Hemocleanse, Inc. · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Sep 30, 1994 after an 828-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided: Sep 30, 1994
Review: 828 days
Class: Class II
Product code: KNT
Recalls: None
Predicates: 0

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

This deviceK923046 Biologic DT-1000 MachineHemocleanse, Inc. · 1994
Descendant · cites it directly · 1 of its ownK984546 Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit…Hemocleanse, Inc. · 1999
Descendant · 2 generations on · 0 of its ownK113313 Molecular Adsorbent Recirculating (Mars)Gambro Renal Products, Inc. · 2012

Most influential descendants

Showing 2 of 2 · See all

K984546Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TKHemocleanse, Inc. · 1999 · cites it directly1descendant
K113313Molecular Adsorbent Recirculating (Mars)Gambro Renal Products, Inc. · 2012 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K923046	Biologic DT-1000 Machine	Hemocleanse, Inc.	1994	—
+1	K984546	Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model…	Hemocleanse, Inc.	1999	—
+2	K113313	Molecular Adsorbent Recirculating (Mars)	Gambro Renal Products, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2012	1	0

FIG. 1 — Lineage of K923046, 1994–2012Source: 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 KNT? 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 KNT device

#1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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
K984546	Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TK	Hemocleanse, Inc.	1999	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, K984546 (Hemocleanse, Inc., 1999) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KNT devices

KNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNT

4in 2025

2007high 16 (2014) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNT

136in 2025

2007high 259 (2014) · low 99 (2016)2026

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

Recalls per year · KNT

13in 2025

2007high 82 (2008) · low 0 (2013)2026

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

Adverse event reports per year · KNT

1,451in 2025

2007high 1,901 (2018) · low 300 (2007)2025

MAUDE reports naming product code KNT, 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	10	118	1	300
2008	10	115	82	867
2009	11	102	9	818
2010	12	104	3	517
2011	7	211	2	531
2012	12	107	1	528
2013	7	128	0	747
2014	16	259	0	1,030
2015	10	140	1	1,048
2016	6	99	3	1,251
2017	9	247	4	1,672
2018	7	149	2	1,901
2019	10	126	2	1,838
2020	5	102	1	1,641
2021	6	121	2	1,655
2022	7	110	1 (1)	1,650
2023	5	162	2	1,863
2024	9	103	0	1,344
2025	4	136	13	1,451
2026	3	105	20	—

https://510kreport.com/device/K923046 · printed Nov 4, 2026

Cite this page

510(k) Report. “K923046: Biologic DT-1000 Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K923046

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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