Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aspen Laboratories, Inc. — Predicate Candidate Screening
55 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
119 days90th percentile
55clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981220 | SYSTEM 7500 ABC ELECTROSURGICAL UNIT | Aspen Laboratories, Inc. | 1998-04-21 | 18 | 0 |
| K963088 | SHEATH, ELECTROSURGICAL PENCIL | Aspen Laboratories, Inc. | 1996-09-13 | 36 | 0 |
| K955834 | SYSTEM 6500 ABC ELECTROSURGICAL UNIT | Aspen Laboratories, Inc. | 1996-07-11 | 198 | 0 |
| K960296 | 4000 ETM | Aspen Laboratories, Inc. | 1996-02-20 | 29 | 0 |
| K953081 | BEAMER PLUS | Aspen Laboratories, Inc. | 1995-10-30 | 119 | 0 |
| K953007 | EXCALIBUR PLUS ELECTROSURGICAL UNIT | Aspen Laboratories, Inc. | 1995-08-21 | 54 | 0 |
| K946104 | SMOKIEVAC ELECTROSURGICAL PENCIL | Aspen Laboratories, Inc. | 1995-04-03 | 110 | 0 |
| K944012 | ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATO | Aspen Laboratories, Inc. | 1994-12-21 | 127 | 0 |
| K924960 | EXCALIBUR ELECTROSURGICAL UNIT | Aspen Laboratories, Inc. | 1993-04-16 | 198 | 0 |
| K913213 | SINGLE USE LEE ELECTRODE | Aspen Laboratories, Inc. | 1992-02-13 | 209 | 0 |
| K896838 | BISTAT ELECTROSURGICAL UNIT 60-5400-001 | Aspen Laboratories, Inc. | 1990-02-13 | 70 | 0 |
| K896839 | MF-450 ELECTROSURGICAL UNIT 60-5500-001 | Aspen Laboratories, Inc. | 1990-02-02 | 59 | 0 |
| K872868 | ASPEN ESMARK BANDAGE | Aspen Laboratories, Inc. | 1987-07-31 | 10 | 0 |
| K872661 | RGB CAMERA SYSTEM | Aspen Laboratories, Inc. | 1987-07-21 | 14 | 0 |
| K871648 | TMJ CANNULA SET | Aspen Laboratories, Inc. | 1987-06-08 | 41 | 0 |
| K870784 | A.T.S. 1500 TOURNIQUET | Aspen Laboratories, Inc. | 1987-03-18 | 20 | 0 |
| K863590 | UNIVERSAL CANNULA SYSTEM | Aspen Laboratories, Inc. | 1986-10-23 | 38 | 0 |
| K862564 | A.C.L. GUIDE KIT | Aspen Laboratories, Inc. | 1986-08-18 | 46 | 0 |
| K854751 | ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE | Aspen Laboratories, Inc. | 1986-02-28 | 94 | 0 |
| K860463 | SINGLE AND DUAL TOURNIQUET CUFF | Aspen Laboratories, Inc. | 1986-02-25 | 19 | 0 |
| K854281 | MAGNETIC RETRIEVER | Aspen Laboratories, Inc. | 1985-12-02 | 39 | 0 |
| K853801 | MENISCAL STITCHING KIT | Aspen Laboratories, Inc. | 1985-10-08 | 27 | 0 |
| K853802 | ATS 500 TOURNIQUET | Aspen Laboratories, Inc. | 1985-10-07 | 26 | 0 |
| K852355 | SINGLE USE ARTHROSCOPY ELECTRODE | Aspen Laboratories, Inc. | 1985-09-03 | 92 | 0 |
| K843801 | MASON EQUIPMENT ORGANIZER & ASPEN | Aspen Laboratories, Inc. | 1984-10-25 | 28 | 0 |
| K841558 | BANANA CUFF | Aspen Laboratories, Inc. | 1984-07-16 | 91 | 0 |
| K831290 | ELECTRODE, FLEXIBLE SUCTION COAGULATOR | Aspen Laboratories, Inc. | 1983-06-03 | 44 | 0 |
| K831291 | ELECTROSURGICAL UNIT-MF 380 #60-1700 | Aspen Laboratories, Inc. | 1983-06-02 | 43 | 0 |
| K823923 | MF 360B ELECTROSURGICAL UNIT | Aspen Laboratories, Inc. | 1983-02-15 | 49 | 0 |
| K813231 | TOURNIQUET | Aspen Laboratories, Inc. | 1981-12-14 | 27 | 0 |
| K810300 | FIBER OPTIC ADAPTERS#60-0893 | Aspen Laboratories, Inc. | 1981-02-27 | 24 | 0 |
| K810299 | FIBER OPTIC ADAPTERS#60-0891 | Aspen Laboratories, Inc. | 1981-02-27 | 24 | 0 |
| K810103 | ADULT ECG ELECTRODE #60-0724 | Aspen Laboratories, Inc. | 1981-01-29 | 13 | 0 |
| K810102 | INFANT ECG ELECTRODE #60-1029 | Aspen Laboratories, Inc. | 1981-01-29 | 13 | 0 |
| K810101 | WATER RESISTANT FOOTSWITCH W/CABLE | Aspen Laboratories, Inc. | 1981-01-29 | 13 | 0 |
| K802774 | FIBER OPTIC ADAPTER #60-0892 | Aspen Laboratories, Inc. | 1980-12-16 | 43 | 0 |
| K802772 | FIBER OPTIC ADAPTER #60-0894 | Aspen Laboratories, Inc. | 1980-12-16 | 43 | 0 |
| K802771 | FIBER OPTIC ADAPTER #60-895 | Aspen Laboratories, Inc. | 1980-12-16 | 43 | 0 |
| K802766 | FIBER OPTIC ADAPTER CAT#60-0898 | Aspen Laboratories, Inc. | 1980-12-16 | 43 | 0 |
| K802773 | FIBER OPTIC LIGHT GUIDE #60-0767 | Aspen Laboratories, Inc. | 1980-12-16 | 43 | 0 |
| K802767 | FIBER OPTIC LIGHT GUIDE CAT#60-0768 | Aspen Laboratories, Inc. | 1980-12-16 | 43 | 0 |
| K802768 | FIBER OPTIC ADAPTER #60-0897 | Aspen Laboratories, Inc. | 1980-12-16 | 43 | 0 |
| K802775 | FIBER OPTIC ADAPTER #60-0896 | Aspen Laboratories, Inc. | 1980-12-16 | 43 | 0 |
| K802770 | FIBER OPTIC HEADLIGHT #60-0766766 | Aspen Laboratories, Inc. | 1980-12-11 | 38 | 0 |
| K802769 | FIBER OPTIC HEADLIGHT #60-0765 | Aspen Laboratories, Inc. | 1980-12-11 | 38 | 0 |
| K801176 | FIBER OPTIC LIGHT SOURCE | Aspen Laboratories, Inc. | 1980-05-28 | 12 | 0 |
| K800597 | REUSABLE HAND-TROL | Aspen Laboratories, Inc. | 1980-04-02 | 16 | 0 |
| K790770 | SAFETY HOLSTER, SINGLE-USE | Aspen Laboratories, Inc. | 1979-05-18 | 28 | 1 |
| K781429 | HAND-TROL CONNECTOR EXTENDER | Aspen Laboratories, Inc. | 1978-08-31 | 10 | 0 |
| K780978 | SINGLE USE ACTIVE ELECTRODE HANDLE | Aspen Laboratories, Inc. | 1978-06-22 | 13 | 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