510(k) · Cleared
ClearedDisposable Pre-calibrated Suction
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · HAW Neurological Stereotaxic Instrument
Cleared on Jan 29, 2021 as substantially equivalent to K082060 (Brainlab AG, 2009) and 1 other predicate after a 217-day review. Its family tree reaches back 5 generations to 1999. 1 of the 10 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 29, 2021
- Review
- 217 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K983831 (1999). 9 ancestors in all. No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 4 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 3 generations backK042391 Kolibri Image Guided Surgery SystemBrainlab AG · 2004
- 2 generations backK082060 Cranial Image Guided Surgery SystemBrainlab AG · 2009
- 1 generation backK092467 Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri…Brainlab AG · 2010 · Recalled (Class I)
- This deviceK201752 Disposable Pre-calibrated SuctionBrainlab AG · 2021
Class I recalls in this family
- K092467 Vectorvision Cranial, Vectorvision Ent, Kolibri…direct predicate · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −4 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −3 | K042391 | Kolibri Image Guided Surgery System | Brainlab AG | 2004 | — |
| −2 | K082060 | Cranial Image Guided Surgery System | Brainlab AG | 2009 | — |
| −1 | K092467 | Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial… | Brainlab AG | 2010 | Class I |
| 0 (this device) | K201752 | Disposable Pre-calibrated Suction | Brainlab AG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K082060 | Cranial Image Guided Surgery SystemSummary page 4…HAW Regulation Number 882.4560 Regulatory Class II Panel Neurology Predicate Devices and K 1. K082060 Cranial ENT IGS System Numbers 2. K092467 Disposable Stylet Manufacturer Brainlab AG… | 2009 |
| * | K092467 | Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential…Summary page 4…ory Class II Panel Neurology Predicate Devices and K 1. K082060 Cranial ENT IGS System Numbers 2. K092467 Disposable Stylet Manufacturer Brainlab AG Contact Information… | 2010 |
| † | K162929 | Stryker Navigation System with CranialMap software application, Stryker CranialMap… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial UnlimitedBrainlab AG · 2010 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- 3 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K082060.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
Disposable Pre-calibrated Suction is an accessory of the Cranial Image Guided Surgery System and intended to be used as a navigated suction device in any surgical procedure in which the use of the Cranial Image Guided Surgery System may be indicated.
Surgical example procedures include:
* Cranial resection of tumors and other lesions
* Resection of skull base tumors or other lesions
* AVM Resection
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201752: Disposable Pre-calibrated Suction.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201752
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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