Monteris Medical,: FDA clearances and approvals

Monteris Medical, has 22 FDA 510(k) clearances (first 2009, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time: 66 days. Since 2017 its median was 62 days, against 90 days for all cleared 510(k)s in the same product codes. openFDA lists 4 product recalls by a recalling firm named Monteris Medical,. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.

510(k) clearances per year

Review time against the same product codes

Since 2017, Monteris Medical,'s cleared 510(k)s took a median 62 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.

Top product codes

Review panels

• General and Plastic Surgery (16)
• Neurology (4)
• Radiology (2)

Most recent Monteris Medical, 510(k) clearances

12 earlier clearances. See the full list in Caduvo.

Recalls

4 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2017-10-05.

Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.

Device clinical trials

Monteris Medical, is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT05075850: PatiEnt Neuropsychological outcomeS After laseR Ablation (Completed, started 2021-09-29)
• NCT02392078: Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (Completed, started 2015-10)
• NCT00747253: Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors (Completed, started 2008-08)

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of Monteris Medical,'s product codes (a text match, not an official crosswalk):

• C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
• C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
• C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
• C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
• C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)

Frequently asked questions

How many FDA 510(k) clearances does Monteris Medical, have?

Monteris Medical, has 22 FDA 510(k) clearances (first 2009, latest 2026), across 4 product codes in 3 review panels.

How long does FDA take to clear Monteris Medical,'s 510(k)s?

The median time from FDA receipt to decision across Monteris Medical,'s cleared 510(k)s is 66 days. Since 2017: 62 days, versus 90 days for all cleared 510(k)s in the same product codes.

What devices does Monteris Medical, make?

Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 16); ONO (Neurosurgical Laser With Mr Thermography, 3); MOS (Coil, Magnetic Resonance, Specialty, 2).

Has Monteris Medical, had device recalls?

openFDA lists 4 product recalls in 3 recall events by a recalling firm whose name matches Monteris Medical,; the most recent began 2017-10-05. Recall firm names are matched by name, so related entities filing under other names are not included.

Next steps

• See all 22 Monteris Medical, clearances with predicates and recalls
• Run predicate analysis for product code GEX, Monteris Medical,'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.

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