510(k) · Cleared

Cleared

Acculeaf

K021338510(k) TraditionalCleared Jan 7, 2003256-day reviewClass II21 CFR 892.5050

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

Direx Systems Corp. · IYE Accelerator, Linear, Medical

Cleared on Jan 7, 2003 as substantially equivalent to K970586 (Brainlab Med. Computersysteme GmbH, 1997) after a 256-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.

Decided: Jan 7, 2003
Review: 256 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970586 (1997). 4 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK970586 Brainlab Micro Multi-Leaf CollimatorBrainlab Med. Computersysteme GmbH · 1997 · Recalled
This deviceK021338 AcculeafDirex Systems Corp. · 2003
Descendant · cites it directly · 3 of its ownK040553 Modification to AcculeafDirex Systems Corp. · 2004
Descendant · 2 generations on · 1 of its ownK052705 DART-12Direx Systems Corp. · 2006
Descendant · 2 generations on · 0 of its ownK071701 Trackleaf-10Direx Systems Corp. · 2007
Descendant · 2 generations on · 0 of its ownK043409 AccuchangerDirex Systems Corp. · 2005

Most influential descendants

Showing 4 of 4 · See all

K040553Modification to AcculeafDirex Systems Corp. · 2004 · cites it directly3descendants
K052705DART-12Direx Systems Corp. · 2006 · 2 generations on1descendant
K071701Trackleaf-10Direx Systems Corp. · 2007 · 2 generations on0descendants
K043409AccuchangerDirex Systems Corp. · 2005 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970586	Brainlab Micro Multi-Leaf Collimator	Brainlab Med. Computersysteme GmbH	1997	1
0 (this device)	K021338	Acculeaf	Direx Systems Corp.	2003	—
+1	K040553	Modification to Acculeaf	Direx Systems Corp.	2004	—
+2	K052705	DART-12	Direx Systems Corp.	2006	—
+2	K071701	Trackleaf-10	Direx Systems Corp.	2007	—
+2	K043409	Accuchanger	Direx Systems Corp.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	1	0
2007	1	0

FIG. 1 — Lineage of K021338, 1997–2007Source: 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 IYE? 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 IYE device

#1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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
*	K970586	Brainlab Micro Multi-Leaf Collimator Summary page 2 …ed by the Radiology Panel. 7-3 Predicate Devices: > BrainLAB Med, GmbH’s Micro-Multi Leaf Collimator (K970586) Performance Standards: No performance standards have been established for such device under Section 514 of the Federal…	Brainlab Med. Computersysteme GmbH	1997	1

Also cleared against K970586: 3 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K040553	Modification to Acculeaf	Direx Systems Corp.	2004	3

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?

Its one ancestor has a recall.
Of its descendants, K040553 (Direx Systems Corp., 2004) has gone furthest, with 3 descendants of its own.
3 other devices also cite its predicate K970586.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, 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	23	44	78	155
2008	14	69	49	114
2009	20	63	22	174
2010	23	74	27	246
2011	11	94	73	280
2012	28	106	20	128
2013	18	88	11	96
2014	20	100	14	124
2015	20	108	8	100
2016	21	97	7	97
2017	23	94	7	125
2018	21	58	7	85
2019	19	83	2	91
2020	20	67	4	74
2021	19	86	5	68
2022	12	172	3	66
2023	18	129	7	128
2024	9	239	1	81
2025	12	170	1	101
2026	14	120	4	—

What is it indicated for?

The AccuLeuf is intended to assr&the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The Accukufenables irregular fields treatments to be performed with finely shaped patterns. In this application the AccuLeuf performs the same function as customized beam shaping blocks, and circular or cut blocks collimators, which have been used for many years

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021338 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021338: Acculeaf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021338

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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