KMJ
49 FDA 510(k) clearances · Product code
86 daysmedian time to decision
222 days90th percentile
49clearances measured
FDA profile
- Official device name
- Lubricant, Patient
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6375
- Medical specialty
- General Hospital
- Adverse events (MAUDE)
- 1998: 3 · 2005: 4 · 2007: 5 · 2008: 3 · 2011: 7 · 2013: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Lubricating Jelly (K142473) | Sion Biotext Medical , Ltd. | 2015-04-13 |
| COLONGLIDE LUBRICANT (K141028) | Pediatric Pharmaceuticals, Inc. | 2014-07-24 |
| COLONGLIDE(R) LUBRICANT (K131617) | Pediatric Pharmaceuticals, Inc. | 2013-10-03 |
| LUBE JELLY SURINGE (K121390) | Nurse Assist, Inc. | 2012-08-10 |
| DUKAL LUBRICATING JELLY (K113689) | Dukal Corporation | 2012-05-04 |
| STERILE LUBRICATING JELLY (K112110) | Jianerkang Medical Dressing Company | 2012-04-10 |
| DYNACOR LUBRICATION GEL (K103718) | Medline Industries, Inc. | 2011-05-10 |
| ULTRA SEAL STERILE LUBRICATING JELLY (K101522) | Ultra Seal Corporation | 2010-12-23 |
| DYNAREX STERILE LUBRICATING JELLY (K092488) | Dynarex Corporation | 2009-12-18 |
| STERI-LUB LUBRICATION GEL (K083189) | Avail Medical Products, Inc. | 2008-11-21 |
| SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL (K073684) | Sheffield Industries, Div. of Faria , Ltd. | 2008-05-22 |
| SPIRUS MEDICAL SURGICAL INSTRUMENT (K080042) | Spirus Medical, Inc. | 2008-04-03 |
| DUREX PLAY WARMER LUBRICANT (K042563) | Ssl Americas, Inc. | 2005-02-23 |
| E-Z LUBRICATING JELLY (K041060) | Chester Labs, Inc. | 2004-05-07 |
| GOOD LUBRICATIONS (K020586) | Biofilm, Inc. | 2003-01-24 |
| PDI STERILE LUBRICATING JELLY (K974768) | Nice-Pak Products, Inc. | 1998-01-16 |
| LUBRIGLIDE (K973557) | Qualis, Inc. | 1997-10-10 |
| LUBRICATING JELLY, LOW VISCOSITY (K961502) | Span-America Medical Systems, Inc. | 1996-07-18 |
| EVRON GEL (K961222) | Pharmaceutical Innovations, Inc. | 1996-06-26 |
| AQUAGEL LUBRICATING JELLY (K951431) | Depuy Healthcare | 1995-07-21 |
| MAXILUBE (K943010) | Mission Pharmacal Co. | 1995-07-19 |
| STERI-LUB LUBRICATION GEL (K944969) | Horizon Medical, Inc. | 1995-02-27 |
| ASTROGLIDE (K935299) | Biofilm, Inc. | 1994-02-18 |
| COMFORT PERSONAL LUBRICANT (K915574) | Hyman, Phelps & McNamara, P.C. | 1993-02-19 |
| OPERAND LUBRICATING JELLY (K912975) | General Medical Co. | 1991-09-27 |
| MENTOR LUBRICATING JELLY (K910790) | Mentor Corp. | 1991-05-03 |
| LUBRICATING JELLY (K903910) | Lake Pharmaceutical, Inc. | 1990-10-26 |
| DISPENSA-LUBE (K903717) | Gam-Med Packaging Corp. | 1990-09-06 |
| OPERAND* LUBRICATING JELLY (K900110) | General Medical Co. | 1990-05-02 |
| OSBON PERSONAL LUBRICANT (K895406) | Osbon Medical Systems, Ltd. | 1989-12-01 |
| OSBON PERSONAL LUBRICANT (K896207) | Osbon Medical Systems, Ltd. | 1989-12-01 |
| MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0 (K882506) | Span-America Medical Systems, Inc. | 1988-09-09 |
| CONDOM-MATE VAGINAL LUBRICANT (K881338) | Upsher-Smith Laboratories, Inc. | 1988-05-16 |
| K-GEL (K872128) | Taro Pharmaceuticals, Inc. | 1987-06-12 |
| AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G (K870742) | Span-America Medical Systems, Inc. | 1987-06-05 |
| LUBRICATING JELLY (K871169) | H & P Industries, Inc. | 1987-04-01 |
| AQUALUBE(TM) (K864556) | Parker Laboratories, Inc. | 1986-12-01 |
| STERILE SALINE SOLUTION (K854155) | I M, Inc. | 1985-12-10 |
| SANA-LUBE (K853653) | Huntington Laboratories, Inc. | 1985-11-13 |
| TODAY PERSONAL LUBRICANT (K851617) | Vli Corp. | 1985-06-06 |
| TOMAC LUBRICATING JELLY (K822143) | American Medical Systems, Inc. | 1982-07-30 |
| WET PACK LINE OF PRODUCTS (K820587) | Abco Dealers, Inc. | 1982-03-26 |
| A.D.T. PROCEDURES TRAY (K812297) | A.D.T. Lab Industries | 1981-09-28 |
| K-Y LUBRICATING JELLY (K810310) | Johnson & Johnson Professionals, Inc. | 1981-04-21 |
| PEDICAT* (K810049) | Pollak (Intl.), Ltd. | 1981-04-21 |
| HYGENIC RUBBER DAM LUBRICANT (K791970) | The Hygenic Corp. | 1979-11-16 |
| LUBRICATING JELLY (K791243) | Abco Dealers, Inc. | 1979-08-03 |
| LUBRICANT, OTRHO PERSONAL (K790087) | Ortho Pharmaceutical Corp. | 1979-02-01 |
| PRESERVE LUBRICANT CODE NO. 43=4035 (K770498) | Codman & Shurtleff, Inc. | 1977-06-20 |
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