Cleared Traditional

K253989 - HARU Orgasm by jack herer water based lubricant (WL-OJ)

Also marketed or referenced as:
HARU Orgasm water based lubricant (WL-OR) HARU STEAMY water based lubricant (WL-ST)

K253989 is an FDA 510(k) clearance for HARU Orgasm by jack herer water based l..., manufactured by Maxigen Biotech, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K253989 · Maxigen Biotech, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
265d
Days
Class 2
Risk

K253989 is an FDA 510(k) clearance for the HARU Orgasm by jack herer water based lubricant (WL-OJ). Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Maxigen Biotech, Inc. (Taoyuan, TW). The FDA issued a Cleared decision on September 3, 2026 after a review of 265 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Maxigen Biotech, Inc. devices

FDA 510(k) Submission Details - K253989

510(k) Number K253989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2025
Decision Date September 03, 2026
Days to Decision 265 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 161d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUC Device Classification - Class 2, Special Controls

Product Code NUC Lubricant, Personal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
Definition This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - NUC Lubricant, Personal

All 244
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