510(k) Report

De Novo · Granted

Granted

OcuCool

DEN230011De NovoGranted Sep 30, 2024592-day review

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

Recensmedical, Inc. · QZQ (no longer in FDA’s product-code list)

Granted on Sep 30, 2024 as a new device type through De Novo after a 592-day review.

Decided
Sep 30, 2024
Review
592 days
Product code
QZQ
Recalls
None

De Novo grants create a new device type without a predicate, so this family tree starts here.

FIG. 1 — Lineage of DEN230011Source: FDA De Novo database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA De Novo 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 QZQ? 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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Does it have a predicate?

De Novo decisions do not claim a predicate device.

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.

What is it indicated for?

OcuCool is a cooling anesthesia device intended for topical application to the conjunctiva and sclera.

OcuCool is intended for the temporary reduction of pain associated with intravitreal injections.

OcuCool is indicated for patients who are allergic to deep penetrating pharmaceutical based anesthetics used for temporarily reducing pain during and following intravitreal injections.

Indications for use as stated in the FDA summary.

More from Recensmedical, Inc.

7 FDA decisions under this applicant name. See the company

  • K253114TargetCool™ (RM-DT02W)Recensmedical, Inc. · 2025
  • K253348TargetCool-eRecensmedical, Inc. · 2025
  • K230599TargetCool™Recensmedical, Inc. · 2023
  • K221234TargetCoolRecensmedical, Inc. · 2022
  • K220674TargetCoolRecensmedical, Inc. · 2022

https://510kreport.com/device/DEN230011 · printed Nov 6, 2026

Cite this page

510(k) Report. “DEN230011: OcuCool.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230011

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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