FDA product code · Obstetrics/Gynecology
HISCondom
Product code HIS covers Condom, a Class II device regulated under 21 CFR 884.5300. FDA has cleared 401 devices in this code, 2 of them in the last 12 months. Median review time across the 401 most recent decisions is 115 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
- 401
What is happening in HIS right now?
HIS (Condom) has two findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-1181-2026). The code is crowded, scoring 66 of 100 — 172 companies hold a clearance here and 2 arrived in the last 12 months (HIS:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1181-2026 |
| Crowding | Context | HIS: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.
How many devices has FDA cleared in HIS?
FDA has cleared 401 devices under product code HIS since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252622 | Male Latex Condom HA | Okamoto USA, Inc. | |
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom | Suretex Limited | |
| K250034 | Natural rubber latex male condom | Shaoguan Regenex Pharmaceuticals Co., Ltd. | |
| K243421 | Lelo Hex Lubricated Natural Rubber Latex Condom | Lelo, Inc. | |
| K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) | Church & Dwight Co., Inc. | |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | Okamoto USA, Inc. | |
| K232279 | LifeStyles NRL Textured Condom | Suretex Limited | |
| K230049 | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT | Ttk Healthcare Limited | |
| K222611 | Male Latex Condoms | Suzhou Colour-Way New Material Co., Ltd. | |
| K220489 | Durex Patronus CloseFit, Durex Patronus Regular | Rb Health (Us), LLC |
How long does FDA review take for HIS?
The median FDA review time for HIS is 115 days, measured across the 401 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 HIS?
openFDA lists 7 recall records against product code HIS. A recall record covers one firm's corrective action and may span many device lots.
Z-1181-2026Open, ClassifiedGOLD STAR DISTRIBUTION INC
Potential exposure of rodents and rodent activity in the distribution center.
Z-1546-2022Open, ClassifiedFamily Dollar Stores, Llc.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Z-1249-2017TerminatedReckitt Benckiser LLC
Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.
Z-0838-2013TerminatedAnsell Healthcare Products LLC
Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned.
Z-0717-2013TerminatedAnsell Healthcare Products LLC
One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.
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 HIS?
MAUDE holds 38 adverse-event reports naming product code HIS, 14 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 HIS unusual?
HIS 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 | |
| 5 | 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 | |
| 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | 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 | |
| 8 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
18 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.
What are the predicate devices in HIS?
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 HIS?
Across the 401 most recent decisions, these applicants filed most often in HIS.
| Applicant | Recent clearances |
|---|---|
| Carter Products | 15 |
| Okamoto USA, Inc. | 14 |
| Mayer Laboratories | 13 |
| Ansell, Inc. | 12 |
| Church & Dwight Co., Inc. | 12 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in HIS files 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 |
|---|---|---|
| Mayer Laboratories, Inc. | 14 | 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 HIS
Get an email the morning anything changes in HIS — 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.