Cleared Traditional

K070623 - PHARMAPAC LUBRICATING JELLY

K070623 is an FDA 510(k) clearance for PHARMAPAC LUBRICATING JELLY, manufactured by Pharmapac, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K070623 · Pharmapac, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
178d
Days
Class 2
Risk

K070623 is an FDA 510(k) clearance for the PHARMAPAC LUBRICATING JELLY. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Pharmapac, LLC (Dekalb, US). The FDA issued a Cleared decision on August 31, 2007 after a review of 178 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.

FDA 510(k) Submission Details - K070623

510(k) Number K070623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2007
Decision Date August 31, 2007
Days to Decision 178 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 161d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NUC Lubricant, Personal

All 248
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K070623.
K-Y BRAND YOURS+MINE
K072421 · Mcneil-Ppc, Inc. · Mar 2008
GLYCERIN & PARABEN FREE ASTROGLIDE
K072647 · Biofilm, Inc. · Jan 2008
K-Y BRAND INTRIGUE INTENSE WARMING SENSATION
K072360 · Mcneil-Ppc, Inc. · Dec 2007
CVS PERSONAL LUBRICANT AND MOISTURIZER
K062682 · Lake Consumer Products, Inc. · Apr 2007
K-Y BRAND WARMING LIQUID
K070545 · Personal Products Co. · Mar 2007
K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING
K062535 · Mcneil-Ppc, Inc. · Jan 2007

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K070623 · PHARMAPAC LUBRICATING JELLY
Download PDF FDA Summary Pharmapac, LLC