510(k) · Cleared

Cleared

Modification to Cavermap Surgical Aid

K031527510(k) SpecialCleared Jun 5, 200321-day reviewClass I21 CFR 876.4730

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

Blue Torch Medical Technologies · FGM Probe And Director, Gastro-Urology

Cleared on Jun 5, 2003 after a 21-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).

Decided: Jun 5, 2003
Review: 21 days
Class: Class I
Product code: FGM
Recalls: None
Predicates: 1

The summary cites one number, which could not be confirmed as its predicate (see the table below).

FIG. 1 — Lineage of K031527Source: FDA 510(k) database · 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.

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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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K970971	FDA’s K970971 is Uro Med Nerve Stimulator Our reading of the summary gave K970971, FDA’s number for Uro Med Nerve Stimulator (Uromed Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Blue Torch Medical Technologies CaverMap Surgical Aid”. Kept off the family tree. Summary page 1 …4730 Probe And Director, Gastro-Urology Predicate Devices used for Substantial Equivalence Blue Torch Medtcal Technologies CaverMap Surgcal A d K970971 Intended Use The Blue Torch Medical Technologies CaverMap Surgical Aid is intended to provide stimulation to the body to locate…	Uromed Corp.	1997	—

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.

How does its category compare?

All FGM devices

FGM Probe And Director, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FGM

FDA has decided no FGM device since 2007.

Median 510(k) review, days · FGM

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

Recalls per year · FGM

No recall names FGM since 2007.

Adverse event reports per year · FGM

1in 2015

2007high 2 (2010) · low 0 (2008)2025

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

View these four charts as a table

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

What is it indicated for?

Read the full statement (116 words)

The Blue Torch Medical Technologies CaverMapB Surgical Aid Video Monitor is a modification to the Blue Torch Medical Technologies CaverMapR Surgical Aid System. The system is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open or laproscopic prostatectomy and open colorectal (surgical) procedures in males. The device aids the surgeon in locating these nerves. The device is designed as an adjunct to the current open or laproscopic prostatectomy and open colorectal procedures in which a nerve sparing technique is used. The Surgical Aid is not designed to replace the surgeon’s expertise in mapping out the neurovascular bundles. Each surgeon’s skill determines whether these nerves are spared regardless of any aid.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031527 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031527: Modification to Cavermap Surgical Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031527

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026