Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
CAT — Predicate Candidate Screening
42 FDA 510(k) clearances under this product code; the 50 most recent screened below.
27 daysmedian FDA review time
98 days90th percentile
42clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011125 | NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIM | Hudson Respiratory Care, Inc. | 2001-06-13 | 61 | 0 |
| K935533 | NASAL CANNULA | Puritas Health Care, Inc. | 1994-02-03 | 79 | 0 |
| K922397 | 4 SURE TM NASAL OXYGEN CANNULA | Boston Pacific Medical, Inc. | 1993-03-18 | 301 | 0 |
| K921496 | SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED | Alpine Specialties, Inc. | 1992-08-14 | 158 | 0 |
| K920573 | CANNULA NASAL OXYGEN | B & F Medical Products, Inc. | 1992-08-11 | 186 | 0 |
| K913421 | NASAL OXYGEN CANNULA, 81585, 81587 & 81589 | Specialty Packaging Producs, Inc. | 1991-10-18 | 79 | 0 |
| K912197 | SKIN SAVER(TM) TUBING HOLDER, MODEL 467 | Alpine Specialties, Inc. | 1991-08-20 | 95 | 0 |
| K911740 | SALTER LABS NEONATAL NASAL OXYGEN CANNULA | Salter Labs | 1991-07-24 | 98 | 0 |
| K902420 | CATHETER, NASAL, OXYGEN | Gainor Medical Europe, Ltd. | 1991-04-17 | 321 | 0 |
| K896036 | THE COMFORTABLE CANNULA | Comfortable Concepts Corp. | 1989-11-17 | 31 | 0 |
| K892435 | KENDALL CURITY OXYGEN NASAL CANNULA | The Kendal Co. | 1989-06-12 | 63 | 0 |
| K884149 | COMFORT STRAP | Comfort Strap Co. | 1988-10-21 | 18 | 0 |
| K863432 | OXYGEN CANNULA EAR WRAP (STYLE B) | Salter Labs | 1986-09-18 | 14 | 0 |
| K863431 | OXYGEN CANNULA EAR WRAP (STYLE A) | Salter Labs | 1986-09-18 | 14 | 0 |
| K860535 | UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) | Andover Medical, Inc. | 1986-04-01 | 48 | 0 |
| K860872 | NASAL CANNULA W/2M & 5M TUBING | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 | 22 | 0 |
| K860261 | CANNULA BAND | T. G. & E. Medical | 1986-02-18 | 25 | 0 |
| K852628 | NASAL ONE | Ashai Co. , Ltd. | 1985-09-18 | 90 | 0 |
| K852625 | OXY-TUBE | Ashai Co. , Ltd. | 1985-09-18 | 90 | 0 |
| K850066 | OMNIMED NASAL OXYGEN CANNULA | Omni Intl., Inc. | 1985-01-24 | 16 | 0 |
| K843467 | PHARMA-PLAST NASAL OXYGEN CANNULA | Zimmar Consulting , Ltd. | 1984-11-19 | 74 | 0 |
| K844083 | STRAIGHT AND BUBBLE OXYGEN TUBING | Hudson Extrusions, Inc. | 1984-10-30 | 11 | 0 |
| K844084 | POLYVINYL CHLORIDE CANNULAS | Hudson Extrusions, Inc. | 1984-10-30 | 11 | 0 |
| K842968 | CHAD ADJUSTABLE CANNULA | Chad Therapeutics, Inc. | 1984-08-29 | 30 | 0 |
| K840897 | OXYGEN TUBING | Medical Technologies of Georgia | 1984-03-16 | 18 | 0 |
| K833127 | ARGYLE NASAL CANNULA | Sherwood Medical Co. | 1983-11-03 | 51 | 0 |
| K823506 | NASAL CANNULA | Seven Harvest Intl. Import & Export | 1982-12-09 | 15 | 0 |
| K811789 | OECO NASAL CANNULA | Oeco | 1981-07-02 | 8 | 0 |
| K810342 | NASAL CANNULA | Todd Industries, Inc. | 1981-03-17 | 35 | 0 |
| K802062 | SOF-TOUCH NASAL CANNULA CAT.#304 & 305 | Hospitak, Inc. | 1980-09-09 | 13 | 0 |
| K791247 | CONPHAR NASAL OXYGEN CANNULA-STERILE | Conphar, Inc. | 1979-07-24 | 18 | 0 |
| K790885 | NASAL, OXYGEN, CANNULA | Airlife, Inc. | 1979-05-17 | 10 | 0 |
| K790056 | CANNULAS, DYNACOR'S NASAL OXYGEN | Medline Industries, Inc. | 1979-02-05 | 27 | 0 |
| K781415 | CANNULA, NASAL, OXYGEN | Vitalab Products Corp. | 1978-09-07 | 23 | 0 |
| K771074 | NASAL OXYGEN CANNULA, #017207 | C.R. Bard, Inc. | 1977-08-04 | 51 | 0 |
| K770996 | OXYGEN CANNULA | Ohio Medical Products | 1977-06-29 | 28 | 0 |
| K770487 | LIGHTWEIGHT PLASTIC CANNULA | Hudson Oxygen Therapy Sales Co. | 1977-03-21 | 7 | 0 |
| K760551 | CANNULA, LARRIAT | Landmark Plastics | 1976-09-05 | 6 | 0 |
| K760337 | CANNULA, ARGYLE NASAL OXYGEN | Sherwood Medical Industries | 1976-08-11 | 12 | 0 |
| K760330 | CANNULA, DISPOSABLE OXYGEN TTHERAPY | Inhal-O-Tech Medical Plastic | 1976-08-04 | 7 | 0 |
| K760218 | CANNULAE, PLASTIC DISPOSABLE NASAL | Manner Medical Products | 1976-08-03 | 22 | 0 |
| K760080 | CANNULA, NASAL, FOR OXYGEN | Inspiron Corp. | 1976-07-15 | 24 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda