Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Devon Industries, Inc. — Predicate Candidate Screening
47 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
128 days90th percentile
47clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961993 | BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) | Devon Industries, Inc. | 1996-07-03 | 43 | 0 |
| K954015 | ABG POINT LOK NEEDLE PROTECTION DEVICE | Devon Industries, Inc. | 1995-11-20 | 87 | 3 |
| K946289 | DEVONS POINT LOK NEEDLE PROTECTION DEVICE | Devon Industries, Inc. | 1995-07-10 | 195 | 0 |
| K945197 | THE SHARPS COLLECTION AND DISPOSAL SYSTEM | Devon Industries, Inc. | 1994-12-02 | 39 | 0 |
| K943892 | POINT OF USE SHARPS A GATOR | Devon Industries, Inc. | 1994-12-02 | 115 | 0 |
| K944114 | PHLEBOTOMY UNIT SHARPS A GATOR | Devon Industries, Inc. | 1994-12-02 | 101 | 0 |
| K945485 | ABG NEEDLE PROTECTION | Devon Industries, Inc. | 1994-11-29 | 21 | 0 |
| K932998 | EASY-ON | Devon Industries, Inc. | 1993-08-18 | 61 | 0 |
| K912824 | DEVON SPONGE COUNTER BAGS | Devon Industries, Inc. | 1991-08-26 | 61 | 0 |
| K894170 | DEVON DISPOSABLE HEAD POSITIONER COVER | Devon Industries, Inc. | 1989-09-07 | 84 | 0 |
| K892660 | HIBERNATION KIT | Devon Industries, Inc. | 1989-08-15 | 124 | 0 |
| K870744 | SURGICAL STARTER KIT | Devon Industries, Inc. | 1987-04-10 | 44 | 0 |
| K862961 | MODIFIED SURGICAL STARTER KIT | Devon Industries, Inc. | 1986-08-20 | 16 | 0 |
| K860248 | 100% COTTON ABSORBENT TOWEL | Devon Industries, Inc. | 1986-02-19 | 26 | 0 |
| K852112 | SURGICAL STARTER KIT | Devon Industries, Inc. | 1985-06-12 | 28 | 0 |
| K844654 | SHARP COLLECTION SYSTEM-SHARP-A-GATOR | Devon Industries, Inc. | 1984-12-12 | 13 | 0 |
| K834135 | STERILE SUTURE BOOTS | Devon Industries, Inc. | 1984-04-27 | 148 | 0 |
| K834142 | ADHESIVE TRACTION TAPE | Devon Industries, Inc. | 1984-04-23 | 144 | 0 |
| K840422 | DEVON HEAD REST | Devon Industries, Inc. | 1984-03-12 | 41 | 0 |
| K840421 | ULNAR NERVE PROTECTOR | Devon Industries, Inc. | 1984-03-12 | 41 | 0 |
| K834127 | INSTRUMENT TIP PROTECTION COVERS | Devon Industries, Inc. | 1984-02-17 | 80 | 0 |
| K834062 | STERILE LABELS | Devon Industries, Inc. | 1984-02-04 | 71 | 0 |
| K834063 | STERILE RUBBER BANDS | Devon Industries, Inc. | 1983-12-22 | 27 | 0 |
| K832368 | CHANGING METHOD OF STERILITY RELEASE | Devon Industries, Inc. | 1983-10-31 | 105 | 0 |
| K830381 | STERILE SAFETY PINS | Devon Industries, Inc. | 1983-03-24 | 48 | 0 |
| K830248 | DEVO'N LOOPS | Devon Industries, Inc. | 1983-03-08 | 42 | 0 |
| K823673 | LITE GUARD | Devon Industries, Inc. | 1983-01-09 | 33 | 0 |
| K821063 | SKIN MARKERS | Devon Industries, Inc. | 1982-06-25 | 110 | 0 |
| K821166 | KOLOR KODE TM | Devon Industries, Inc. | 1982-05-13 | 17 | 0 |
| K812444 | RADIATION STERILIZATION FOR NEEDLE CNTR | Devon Industries, Inc. | 1981-12-14 | 108 | 0 |
| K811712 | TIP WIPE | Devon Industries, Inc. | 1981-07-20 | 33 | 0 |
| K803055 | ELECTROSURGICAL TIP CLEANER & HOLDER | Devon Industries, Inc. | 1981-02-12 | 72 | 0 |
| K801421 | TUBE HOLDER | Devon Industries, Inc. | 1980-07-28 | 41 | 0 |
| K790538 | SPONGE COUNTER | Devon Industries, Inc. | 1979-04-04 | 15 | 0 |
| K790084 | SURGICAL RULER AND PEN | Devon Industries, Inc. | 1979-02-26 | 41 | 0 |
| K780865 | MAGNETIC DRAPE - INSTRUMENT HOLDER | Devon Industries, Inc. | 1978-08-21 | 83 | 0 |
| K780866 | CHEST ROLLS HOLDER | Devon Industries, Inc. | 1978-08-14 | 76 | 0 |
| K780867 | PAD HOLDER KIT | Devon Industries, Inc. | 1978-08-14 | 76 | 0 |
| K780868 | CHEST ROLLS | Devon Industries, Inc. | 1978-08-14 | 76 | 0 |
| K771123 | SURGICAL INSTRUMENT PROTECTOR | Devon Industries, Inc. | 1977-10-28 | 128 | 0 |
| K771124 | INSTRUMENT TRAY PAD | Devon Industries, Inc. | 1977-10-28 | 128 | 0 |
| K771125 | POLYURETHANE PROD. FOR I.V. NEEDLES | Devon Industries, Inc. | 1977-08-02 | 41 | 0 |
| K770698 | COUNTER, SPONGE | Devon Industries, Inc. | 1977-05-06 | 21 | 0 |
| K760951 | DEVON COOL FACE | Devon Industries, Inc. | 1976-12-30 | 59 | 0 |
| K760950 | DEVON KNEE STRAP | Devon Industries, Inc. | 1976-11-11 | 10 | 0 |
| K760320 | PROTECTOR, SURGICAL INSTRUMENT | Devon Industries, Inc. | 1976-09-30 | 66 | 0 |
| K760328 | RAZOR, DISPOSABLE | Devon Industries, Inc. | 1976-08-11 | 15 | 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