510(k) · Cleared

Cleared

Acessa Guidance System

K132744510(k) TraditionalCleared May 27, 2014266-day reviewClass II21 CFR 884.4160

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

Halt Medical, Inc. · HFG Coagulator, Laparoscopic, Unipolar (And Accessories)

Cleared on May 27, 2014 as substantially equivalent to K121479 (Inneroptic Technology, Inc., 2012) after a 266-day review. Its family tree reaches back 4 generations to 1988. 1 later device descends from it.

Decided: May 27, 2014
Review: 266 days
Class: Class II
Product code: HFG
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K882383 (1988). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK882383 Maggi Series Ultra. Needle, Biopsy/Catheter GuidesCIVCO Medical Instruments Co., Inc. · 1988
3 generations backK974432 Ultraguide 1000Ultraguide, Ltd. · 1998
2 generations backK083728 Invision SystemInneroptic Technology, Inc. · 2009
1 generation backK121479 AIMInneroptic Technology, Inc. · 2012
This deviceK132744 Acessa Guidance SystemHalt Medical, Inc. · 2014
Descendant · cites it directly · 0 of its ownK181124 Acessa ProVu SystemAcessa Health, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all

K181124Acessa ProVu SystemAcessa Health, Inc. · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K882383	Maggi Series Ultra. Needle, Biopsy/Catheter Guides	CIVCO Medical Instruments Co., Inc.	1988	—
−3	K974432	Ultraguide 1000	Ultraguide, Ltd.	1998	—
−2	K083728	Invision System	Inneroptic Technology, Inc.	2009	—
−1	K121479	AIM	Inneroptic Technology, Inc.	2012	—
0 (this device)	K132744	Acessa Guidance System	Halt Medical, Inc.	2014	—
+1	K181124	Acessa ProVu System	Acessa Health, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	2	0
1996	1	0
1999	1	0
2000	3	0
2001	1	0
2003	1	0
2006	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K132744, 1988–2018Source: 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 HFG? 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

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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
*	K121479	AIM Summary page 1 …Obstetrics and Gynecology Classification Regulation 21 CFR §884.4160 Legally Marketed Device to which AIM System (K121479) substantial equivalence is claimed Intended Use The Acessa Guidance System is indicated for enhancing the ultrasonic…	Inneroptic Technology, Inc.	2012	—

Also cleared against K121479: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K181124	Acessa ProVu System	Acessa Health, Inc.	2018	0

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 26 years and passes through 4 companies; a new generation was cleared every 9.2 years on median.
2 of the 16 ancestors have a recall of any class.
Of its descendants, K181124 (Acessa Health, Inc., 2018) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K121479.

How does its category compare?

All HFG devices

HFG Coagulator, Laparoscopic, Unipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · HFG

1in 2018

2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HFG

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

Recalls per year · HFG

No recall names HFG since 2007.

Adverse event reports per year · HFG

32in 2025

2007high 36 (2023) · low 0 (2008)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	2
2008	0	—	0
2009	0	—	2
2010	1	—	2
2011	0	—	0
2012	1	—	0
2013	0	—	0
2014	2	—	3
2015	0	—	2
2016	0	—	5
2017	0	—	2
2018	1	—	3
2019	0	—	5
2020	0	—	6
2021	0	—	20
2022	0	—	20
2023	0	—	36
2024	0	—	21
2025	0	—	32
2026	0	—	—

What is it indicated for?

The Acessa Guidance System Is Indicated for enhancing the ultrasonic image of the Acessa Handpiece and for predicting its future path on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound Imaging system. The device Isintended as an optional accessory for use during the Acessa System procedure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132744 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132744: Acessa Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132744

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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