FDA product code · Obstetrics/Gynecology
NUCLubricant, Personal
Product code NUC covers Lubricant, Personal, a Class II device regulated under 21 CFR 884.5300. FDA has cleared 246 devices in this code, 13 of them in the last 12 months. Median review time across the 246 most recent decisions is 163 days. openFDA lists 7 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 884.5300
- Review panel
- Obstetrics/Gynecology
- Clearances
- 246
What is happening in NUC right now?
NUC (Lubricant, Personal) has three findings, most consequential first. 10 first-time filers in the last 12 months, including PINKSLIP, LLC and Pcca, Inc (K261177, K261909, K254011, K261292, K254101). Clearances are running 44% faster — a median 91 days over the last 12 months against 163 days all-time (elapsed calendar days, not FDA review days) (NUC:review_time:12m). The code is crowded, scoring 94 of 100 — 126 companies hold a clearance here and 13 arrived in the last 12 months (NUC:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K261177, K261909, K254011, K261292, K254101 |
| Review time | Context | NUC:review_time:12m |
| Crowding | Context | NUC:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code NUC cover?
NUC is FDA's product code for Lubricant, Personal, a Class II device regulated under 21 CFR 884.5300.
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.
Source: openFDA device/classification · record NUC · retrieved
How many devices has FDA cleared in NUC?
FDA has cleared 246 devices under product code NUC since the 510(k) programme began in 1976, 13 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | PINKSLIP, LLC | |
| K261909 | Plum Vagiceuticals Vaginal Moisturizing Suppositories | PCCA, Inc. | |
| K254011 | Flow Water-Based Personal Lubricant | LBDO Group, Inc. | |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | PR Personal Care Laboratories | |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) | Hathor Professional Skincare , Ltd. | |
| K260068 | pjur NATURE Touch, 100 ml | Pjur Group Luxembourg S.A. | |
| K254101 | Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. | |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) | Hudi Pharma Srl | |
| K253983 | Water-based lubricant | Guangzhou Haoyimai Trading Co., Ltd. | |
| K251011 | Chiavaye Personal Moisturizer | Unipack, LLC |
How long does FDA review take for NUC?
The median FDA review time for NUC is 163 days, measured across the 246 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in NUC?
openFDA lists 7 recall records against product code NUC. A recall record covers one firm's corrective action and may span many device lots.
Z-1547-2022Open, ClassifiedFamily Dollar Stores, Llc.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Z-0873-2013TerminatedMc-NEIL-PPC, Inc.
This product is not cleared for marketing in the US.
Z-0874-2013TerminatedMc-NEIL-PPC, Inc.
This product is not cleared for marketing in the US.
Z-0875-2013TerminatedMc-NEIL-PPC, Inc.
This product is not cleared for marketing in the US.
Z-2467-2012TerminatedMc-NEIL-PPC, Inc.
Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS. JJHP received a Warning Letter on May 23, 2012 indicating that thi
Showing the 5 most recently initiated of 7. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for NUC?
MAUDE holds 37 adverse-event reports naming product code NUC, 7 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in NUC unusual?
NUC does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history |
23 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered NUC in the last year?
8 companies filed in NUC for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| PINKSLIP, LLC | K261177 | |
| Pcca, Inc. | K261909 | |
| LBDO Group, Inc. | K254011 | |
| PR Personal Care Laboratories | K261292 | |
| Golden Isles Medical, Inc. | K254101 | |
| Hudi Pharma Srl | K260007 | |
| Guangzhou Haoyimai Trading Co., Ltd. | K253983 | |
| Unipack, LLC | K251011 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in NUC?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in NUC?
Across the 246 most recent decisions, these applicants filed most often in NUC.
| Applicant | Recent clearances |
|---|---|
| Biofilm, Inc. | 13 |
| United Consortium | 13 |
| CC Wellness, LLC | 10 |
| Church & Dwight Co., Inc. | 8 |
| Rb Health (Us), LLC | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in NUC file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| United Consortium, Inc. | 14 | 2 |
| Rb Health (Us), LLC | 9 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch NUC
Get an email the morning anything changes in NUC — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.